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NCT03143153 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin · Source last updated 2026-02-17

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
All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months)
Other-event reporting threshold
5%

All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Nivolumab + Ipilimumab

Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.

243 / 322301 / 322270 / 325
Arm B: Nivolumab + Chemotherapy

Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.

226 / 310307 / 310273 / 321
Arm C: Chemotherapy

Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.

174 / 304288 / 304286 / 324

Group identifiers: EG000: Arm A: Nivolumab + Ipilimumab · EG001: Arm B: Nivolumab + Chemotherapy · EG002: Arm C: Chemotherapy

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      304
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Immune thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Myelosuppression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Pancytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Splenic haematoma

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      108
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      304
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      304
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      304
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      142
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      138
      num At Risk
      304
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      304
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      304
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      207
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      172
      num At Risk
      304
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      75
      num At Risk
      304
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      304
    term
    Vomiting
Complete source fields
description
All cause mortality was collected for all the randomized participants and serious and non-serious adverse events were collected for treated population.
event Groups
  1. deaths Num Affected
    270
    deaths Num At Risk
    325
    description
    Participants will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion every 2 weeks and ipilimumab as a 30-minute infusion 1 mg/kg every 6 weeks.
    id
    EG000
    other Num Affected
    301
    other Num At Risk
    322
    serious Num Affected
    243
    serious Num At Risk
    322
    title
    Arm A: Nivolumab + Ipilimumab
  2. deaths Num Affected
    273
    deaths Num At Risk
    321
    description
    Participants will receive treatment with nivolumab 240 mg as a 30-minute infusion on Day 1 and Day 15, fluorouracil 800 mg/m²/day as an IV continuous infusion on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
    id
    EG001
    other Num Affected
    307
    other Num At Risk
    310
    serious Num Affected
    226
    serious Num At Risk
    310
    title
    Arm B: Nivolumab + Chemotherapy
  3. deaths Num Affected
    286
    deaths Num At Risk
    324
    description
    Participants will receive treatment with fluorouracil 800 mg/m²/day as an IV continuous infusion from Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² as a 30- to 120-minute infusion on Day 1 of 4-week cycle.
    id
    EG002
    other Num Affected
    288
    other Num At Risk
    304
    serious Num Affected
    174
    serious Num At Risk
    304
    title
    Arm C: Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      156
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      108
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      304
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      304
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      304
    term
    Abdominal pain upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      142
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      138
      num At Risk
      304
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      304
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      304
    term
    Dysphagia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      207
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      172
      num At Risk
      304
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      75
      num At Risk
      304
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      304
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      304
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      304
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Immune thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Myelosuppression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      304
    term
    Pancytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      322
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      310
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      304
    term
    Splenic haematoma
time Frame
All cause mortality was collected till 88 months and Serious and Non-Serious AEs from first dose (Day 1) to 100 days post last dose (up to 43 months)

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Preserved source evidence · Not medical advice