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NCT00154102 · ADVERSE EVENTS

Adverse events

Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) · Source last updated 2017-01-30

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
Time from first dose up to 30 days after the last dose of study treatment.
Other-event reporting threshold
5%

Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cetuximab Plus FOLFIRI

Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.

263 / 600593 / 600Not reported / Not reported
FOLFIRI Alone

Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects

204 / 602591 / 602Not reported / Not reported

Group identifiers: EG000: Cetuximab Plus FOLFIRI · EG001: FOLFIRI Alone

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 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      602
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    FEBRILE BONE MARROW APLASIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      602
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      602
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      602
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      602
    term
    PANCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    term
    PLATELET TOXICITY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    term
    THROMBOCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    term
    ACUTE CORONARY SYNDROME
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    ACUTE MYOCARDIAL INFARCTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    ANGINA PECTORIS

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 10.0
    stats
    1. group Id
      EG000
      num Affected
      272
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      249
      num At Risk
      602
    term
    NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      127
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      602
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      127
      num At Risk
      602
    term
    ANAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      602
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      602
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      602
    term
    CONJUNCTIVITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      377
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      353
      num At Risk
      602
    term
    DIARRHOEA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      322
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      359
      num At Risk
      602
    term
    NAUSEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      231
      num At Risk
      602
    term
    VOMITING
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      169
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      602
    term
    STOMATITIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      154
      num At Risk
      602
    term
    ABDOMINAL PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      602
    term
    CONSTIPATION
Complete source fields
description
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
event Groups
  1. description
    Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
    id
    EG000
    other Num Affected
    593
    other Num At Risk
    600
    serious Num Affected
    263
    serious Num At Risk
    600
    title
    Cetuximab Plus FOLFIRI
  2. description
    Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops. Safety population: includes all treated subjects
    id
    EG001
    other Num Affected
    591
    other Num At Risk
    602
    serious Num Affected
    204
    serious Num At Risk
    602
    title
    FOLFIRI Alone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      272
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      249
      num At Risk
      602
    term
    NEUTROPENIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      127
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      602
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      127
      num At Risk
      602
    term
    ANAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      602
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      602
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      602
    term
    CONJUNCTIVITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      377
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      353
      num At Risk
      602
    term
    DIARRHOEA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      322
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      359
      num At Risk
      602
    term
    NAUSEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      231
      num At Risk
      602
    term
    VOMITING
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      169
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      602
    term
    STOMATITIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      154
      num At Risk
      602
    term
    ABDOMINAL PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      602
    term
    CONSTIPATION
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      602
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    FEBRILE BONE MARROW APLASIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      602
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      602
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      602
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      602
    term
    PANCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    term
    PLATELET TOXICITY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    term
    THROMBOCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    term
    ACUTE CORONARY SYNDROME
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    ACUTE MYOCARDIAL INFARCTION
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      600
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    term
    ANGINA PECTORIS
time Frame
Time from first dose up to 30 days after the last dose of study treatment.

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Preserved source evidence · Independent clinical review pending · Not medical advice