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NCT01412957 · ADVERSE EVENTS

Adverse events

Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer · Source last updated 2017-03-15

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
From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.
Other-event reporting threshold
5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

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

Not reported

48 / 189174 / 189Not reported / Not reported
BSC Alone

Participants received best supportive care until disease progression, withdrawal of consent, or death.

37 / 18874 / 188Not reported / Not reported

Group identifiers: EG000: Panitumumab Plus BSC · EG001: BSC 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 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Bone marrow toxicity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Angina unstable
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Myocardial ischaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Pyloric stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Diplopia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      188
    term
    Abdominal pain

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 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      188
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      188
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      188
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      188
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    term
    Dyspepsia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      188
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      188
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      188
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      188
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Paronychia
Complete source fields
description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
event Groups
  1. id
    EG000
    other Num Affected
    174
    other Num At Risk
    189
    serious Num Affected
    48
    serious Num At Risk
    189
    title
    Panitumumab Plus BSC
  2. description
    Participants received best supportive care until disease progression, withdrawal of consent, or death.
    id
    EG001
    other Num Affected
    74
    other Num At Risk
    188
    serious Num Affected
    37
    serious Num At Risk
    188
    title
    BSC Alone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      188
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      188
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      188
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      188
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    term
    Dyspepsia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      188
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      188
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      188
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      188
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Conjunctivitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Paronychia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      188
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Bone marrow toxicity
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Acute myocardial infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Angina unstable
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Cardiac failure congestive
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Myocardial ischaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Pyloric stenosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Vertigo
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      188
    term
    Diplopia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      188
    term
    Abdominal discomfort
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      189
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      188
    term
    Abdominal pain
time Frame
From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.

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