Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03581786 · ADVERSE EVENTS

Adverse events

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer · Source last updated 2025-09-02

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
Up to approximately 48 months
Other-event reporting threshold
5%

All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo Combine With Chemotherapy

Placebos: placebo combine with chemotherapy

62 / 143143 / 14367 / 143
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

64 / 146146 / 14647 / 146

Group identifiers: EG000: Placebo Combine With Chemotherapy · EG001: TORIPALIMAB INJECTION(JS001 )Combine With 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
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      146
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      146
    term
    Infections and infestations
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      146
    term
    Metabolism and nutrition disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      146
    term
    General disorders and administration site
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      146
    term
    Gastrointestinal disorders
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      146
    term
    Hepatobiliary disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      146
    term
    Respiratory, thoracic and mediastinal disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      146
    term
    Skin and subcutaneous tissue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    term
    Investigations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      146
    term
    Nervous system disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    term
    Cardiac disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      146
    term
    Musculoskeletal and connective tissue disorders

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
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      143
      num At Risk
      146
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      135
      num At Risk
      146
    term
    Gastrointestinal disorders
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      146
    term
    Metabolism and nutrition disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      146
    term
    Investigations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      146
    term
    General disorders and administration site conditions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      146
    term
    Nervous system disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      146
    term
    Respiratory, thoracic and mediastinal disorders Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      146
    term
    Skin and subcutaneous tissue disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      146
    term
    Infections and infestations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      146
    term
    Musculoskeletal and connective tissue disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      146
    term
    Endocrine disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      146
    term
    Psychiatric disorders
Complete source fields
description
All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
event Groups
  1. deaths Num Affected
    67
    deaths Num At Risk
    143
    description
    Placebos: placebo combine with chemotherapy
    id
    EG000
    other Num Affected
    143
    other Num At Risk
    143
    serious Num Affected
    62
    serious Num At Risk
    143
    title
    Placebo Combine With Chemotherapy
  2. deaths Num Affected
    47
    deaths Num At Risk
    146
    description
    TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
    id
    EG001
    other Num Affected
    146
    other Num At Risk
    146
    serious Num Affected
    64
    serious Num At Risk
    146
    title
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      143
      num At Risk
      146
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      138
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      135
      num At Risk
      146
    term
    Gastrointestinal disorders
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      146
    term
    Metabolism and nutrition disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      146
    term
    Investigations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      146
    term
    General disorders and administration site conditions
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      78
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      146
    term
    Nervous system disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      146
    term
    Respiratory, thoracic and mediastinal disorders Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      146
    term
    Skin and subcutaneous tissue disorders
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      146
    term
    Infections and infestations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      146
    term
    Musculoskeletal and connective tissue disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      146
    term
    Endocrine disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      146
    term
    Psychiatric disorders
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      146
    term
    Blood and lymphatic system disorders
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      146
    term
    Infections and infestations
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      146
    term
    Metabolism and nutrition disorders
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      146
    term
    General disorders and administration site
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      146
    term
    Gastrointestinal disorders
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      146
    term
    Hepatobiliary disorders
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      146
    term
    Respiratory, thoracic and mediastinal disorders
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      146
    term
    Skin and subcutaneous tissue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      146
    term
    Investigations
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      146
    term
    Nervous system disorders
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      146
    term
    Cardiac disorders
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      143
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      146
    term
    Musculoskeletal and connective tissue disorders
time Frame
Up to approximately 48 months

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

Preserved source evidence · Not medical advice