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NCT02839343 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer · Source last updated 2022-05-24

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
Adverse events and Serious Adverse events were collected for 2 years and all cause mortality was collected for 4 years and 7 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)

Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.

33 / 6664 / 6642 / 66
Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)

Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.

28 / 5555 / 5526 / 55

Group identifiers: EG000: Arm 1 (mFOLFIRINOX + Surgery + FOLFOX) · EG001: Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
      num Events
      6
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
      num Events
      8
    term
    Diarrhea

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
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      66
      num Events
      118
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      55
      num Events
      112
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Ear and labyrinth disorders - Oth spec
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Ear pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      16
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Dry eye
Complete source fields
event Groups
  1. deaths Num Affected
    42
    deaths Num At Risk
    66
    description
    Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
    id
    EG000
    other Num Affected
    64
    other Num At Risk
    66
    serious Num Affected
    33
    serious Num At Risk
    66
    title
    Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)
  2. deaths Num Affected
    26
    deaths Num At Risk
    55
    description
    Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.
    id
    EG001
    other Num Affected
    55
    other Num At Risk
    55
    serious Num Affected
    28
    serious Num At Risk
    55
    title
    Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      66
      num Events
      118
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      55
      num Events
      112
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Thrombotic thrombocytopenic purpura
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Cardiac disorders - Other, specify
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Ear and labyrinth disorders - Oth spec
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Ear pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      16
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Dry eye
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
      num Events
      0
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Heart failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
      num Events
      6
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
      num Events
      1
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      66
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
      num Events
      2
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
      num Events
      8
    term
    Diarrhea
time Frame
Adverse events and Serious Adverse events were collected for 2 years and all cause mortality was collected for 4 years and 7 months.

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