Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00113763 · ADVERSE EVENTS

Adverse events

Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer · 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
First dose through maximum of safety FU or 30 days after last dose
Other-event reporting threshold
5%

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Safety Analysis set includes all randomized patients, analyzed according to the treatment they actually received. Hence, 2 patients randomized to Panitumumab Plus BSC treatment group are analyzed in the BSC Alone group for safety.

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

Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.

101 / 229224 / 229Not reported / Not reported
BSC Alone

Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.

62 / 234171 / 234Not 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 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    ARRHYTHMIA SUPRAVENTRICULAR
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    CARDIO-RESPIRATORY ARREST
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    CARDIOMYOPATHY
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    PERICARDITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    SUPRAVENTRICULAR TACHYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    ENDOPHTHALMITIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    ABDOMINAL DISTENSION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      234
    term
    ABDOMINAL PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    ABDOMINAL PAIN LOWER

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 9.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      234
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    GROWTH OF EYELASHES
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      234
    term
    ABDOMINAL PAIN
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      234
    term
    ABDOMINAL PAIN UPPER
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      234
    term
    CONSTIPATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      234
    term
    DIARRHOEA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      234
    term
    NAUSEA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      234
    term
    STOMATITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      234
    term
    VOMITING
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      234
    term
    ASTHENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      234
    term
    FATIGUE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      234
    term
    GENERAL PHYSICAL HEALTH DETERIORATION
Complete source fields
description
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Safety Analysis set includes all randomized patients, analyzed according to the treatment they actually received. Hence, 2 patients randomized to Panitumumab Plus BSC treatment group are analyzed in the BSC Alone group for safety.
event Groups
  1. description
    Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
    id
    EG000
    other Num Affected
    224
    other Num At Risk
    229
    serious Num Affected
    101
    serious Num At Risk
    229
    title
    Panitumumab Plus BSC
  2. description
    Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
    id
    EG001
    other Num Affected
    171
    other Num At Risk
    234
    serious Num Affected
    62
    serious Num At Risk
    234
    title
    BSC Alone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      234
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    GROWTH OF EYELASHES
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      234
    term
    ABDOMINAL PAIN
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      234
    term
    ABDOMINAL PAIN UPPER
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      234
    term
    CONSTIPATION
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      234
    term
    DIARRHOEA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      234
    term
    NAUSEA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      234
    term
    STOMATITIS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      234
    term
    VOMITING
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      234
    term
    ASTHENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      234
    term
    FATIGUE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      234
    term
    GENERAL PHYSICAL HEALTH DETERIORATION
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      234
    term
    ARRHYTHMIA SUPRAVENTRICULAR
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    CARDIO-RESPIRATORY ARREST
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    CARDIOMYOPATHY
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    PERICARDITIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    SUPRAVENTRICULAR TACHYCARDIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    ENDOPHTHALMITIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    ABDOMINAL DISTENSION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      234
    term
    ABDOMINAL PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 9.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      229
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      234
    term
    ABDOMINAL PAIN LOWER
time Frame
First dose through maximum of safety FU or 30 days after last dose

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice