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NCT00364013 · ADVERSE EVENTS

Adverse events

PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy · Source last updated 2022-11-07

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 around 7.7 months in the Panitumumab arm, and around 6.7 months in the Chemo alone arm.
Other-event reporting threshold
5%

One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.

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

Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

262 / 585577 / 585Not reported / Not reported
FOLFOX Alone

Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.

198 / 584571 / 584Not reported / Not reported

Group identifiers: EG000: Panitumumab Plus FOLFOX · EG001: FOLFOX 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
      8
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      584
    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
      15
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      584
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    term
    Hyperviscosity syndrome
  4. 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
      585
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      584
    term
    Idiopathic thrombocytopenic purpura
  5. 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
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    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
      11
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      584
    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
      585
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      584
    term
    Splenic lesion
  8. 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
      585
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      584
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      584
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    term
    Angina pectoris
  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
      585
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      584
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    term
    Atrial fibrillation

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
      84
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      584
    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
      48
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      584
    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
      315
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      353
      num At Risk
      584
    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
      115
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      584
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      584
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      584
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      156
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      133
      num At Risk
      584
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      584
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      154
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      155
      num At Risk
      584
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      349
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      282
      num At Risk
      584
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      584
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      584
    term
    Dyspepsia
Complete source fields
description
One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
event Groups
  1. description
    Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    577
    other Num At Risk
    585
    serious Num Affected
    262
    serious Num At Risk
    585
    title
    Panitumumab Plus FOLFOX
  2. description
    Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
    id
    EG001
    other Num Affected
    571
    other Num At Risk
    584
    serious Num Affected
    198
    serious Num At Risk
    584
    title
    FOLFOX 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
      84
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      81
      num At Risk
      584
    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
      48
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      584
    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
      315
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      353
      num At Risk
      584
    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
      115
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      584
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      103
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      584
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      584
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      156
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      133
      num At Risk
      584
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      584
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      154
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      155
      num At Risk
      584
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      349
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      282
      num At Risk
      584
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      584
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      584
    term
    Dyspepsia
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
      8
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      584
    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
      15
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      584
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    term
    Hyperviscosity syndrome
  4. 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
      585
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      584
    term
    Idiopathic thrombocytopenic purpura
  5. 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
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    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
      11
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      584
    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
      585
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      584
    term
    Splenic lesion
  8. 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
      585
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      584
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      584
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    term
    Angina pectoris
  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
      585
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      584
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      585
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      584
    term
    Atrial fibrillation
time Frame
The median treatment period was around 7.7 months in the Panitumumab arm, and around 6.7 months in the Chemo alone arm.

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