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NCT03943667 · ADVERSE EVENTS

Adverse events

Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma · Source last updated 2026-01-15

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
GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
GEMPAX

Gemcitabine + Paclitaxel until progression Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest. Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.

71 / 140138 / 140131 / 140
Control

Gemcitabine alone until progression Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.

26 / 7122 / 7168 / 71

Group identifiers: EG000: GEMPAX · EG001: Control

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 (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    BICYTOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    ANGINA PECTORIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    ATRIAL FIBRILLATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    CARDIAC FAILURE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    APLASIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    VISION BLURRED
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    term
    ABDOMINAL PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    ANASTOMOTIC ULCER PERFORATION

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 (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      71
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    CARDIAC FAILURE
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    APLASIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    ABDOMINAL PAIN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    DIARRHOEA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    NAUSEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    STOMATITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    VOMITING
Complete source fields
event Groups
  1. deaths Num Affected
    131
    deaths Num At Risk
    140
    description
    Gemcitabine + Paclitaxel until progression Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest. Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
    id
    EG000
    other Num Affected
    138
    other Num At Risk
    140
    serious Num Affected
    71
    serious Num At Risk
    140
    title
    GEMPAX
  2. deaths Num Affected
    68
    deaths Num At Risk
    71
    description
    Gemcitabine alone until progression Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    71
    serious Num Affected
    26
    serious Num At Risk
    71
    title
    Control
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      71
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      71
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    CARDIAC FAILURE
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    APLASIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    ABDOMINAL PAIN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    DIARRHOEA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    NAUSEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    STOMATITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    VOMITING
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    BICYTOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    ANGINA PECTORIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    ATRIAL FIBRILLATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    CARDIAC FAILURE
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    APLASIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      71
    term
    VISION BLURRED
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      71
    term
    ABDOMINAL PAIN
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (Unspecified)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      140
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      71
    term
    ANASTOMOTIC ULCER PERFORATION
time Frame
GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.

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