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NCT00339183 · ADVERSE EVENTS

Adverse events

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone · Source last updated 2022-09-23

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
The median treatment period was approximately 6.2 months in the Panitumumab plus FOLFIRI arm, and 4.7 months in the FOLFIRI Alone arm.
Other-event reporting threshold
5%

One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

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

Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.

232 / 587575 / 587Not reported / Not reported
FOLFIRI Alone

Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.

175 / 594546 / 594Not reported / Not reported

Group identifiers: EG000: Panitumumab 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 12.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      594
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      594
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      594
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      594
    term
    Arteriospasm coronary
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      594
    term
    Bradycardia

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 12.0
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      594
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      594
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      207
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      209
      num At Risk
      594
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      594
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      594
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      594
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      594
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      139
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      125
      num At Risk
      594
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      372
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      321
      num At Risk
      594
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      594
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      594
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      276
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      269
      num At Risk
      594
    term
    Nausea
Complete source fields
description
One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
event Groups
  1. description
    Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
    id
    EG000
    other Num Affected
    575
    other Num At Risk
    587
    serious Num Affected
    232
    serious Num At Risk
    587
    title
    Panitumumab Plus FOLFIRI
  2. description
    Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    EG001
    other Num Affected
    546
    other Num At Risk
    594
    serious Num Affected
    175
    serious Num At Risk
    594
    title
    FOLFIRI Alone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      594
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      594
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      207
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      209
      num At Risk
      594
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      594
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      594
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      594
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      594
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      139
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      125
      num At Risk
      594
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      372
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      321
      num At Risk
      594
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      594
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      594
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      276
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      269
      num At Risk
      594
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      594
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      594
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      594
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      594
    term
    Arrhythmia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      594
    term
    Arteriospasm coronary
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      587
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      594
    term
    Bradycardia
time Frame
The median treatment period was approximately 6.2 months in the Panitumumab plus FOLFIRI arm, and 4.7 months in the FOLFIRI Alone arm.

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