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NCT05255601 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma · Source last updated 2026-06-26

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 (ACM) was assessed from randomization until their study completion (Up to approximately 38 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 135 days post last dose (Up to approximately 11 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part A - Flat Dosing (AF)

Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W

1 / 44 / 40 / 4
Part A - Age/Weight-based Dosing (AW)

Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W

1 / 11 / 11 / 1

Group identifiers: EG000: Part A - Flat Dosing (AF) · EG001: Part A - Age/Weight-based Dosing (AW)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Facial pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Skin infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Malignant neoplasm progression
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Spinal cord compression

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Dental caries
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Stomatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Toothache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants received treatment with Relatlimab 160 mg + Nivolumab 480 mg Q4W
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part A - Flat Dosing (AF)
  2. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participant received treatment with Relatlimab 2 mg/kg + Nivolumab 6 mg/kg Q4W
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Part A - Age/Weight-based Dosing (AW)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hyperthyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Dental caries
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Stomatitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Toothache
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Facial pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    term
    Skin infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Malignant neoplasm progression
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 28.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    term
    Spinal cord compression
time Frame
All-Cause Mortality (ACM) was assessed from randomization until their study completion (Up to approximately 38 months). Adverse Events (AEs) and Serious Adverse (SAEs) were assessed from first dose to 135 days post last dose (Up to approximately 11 months)

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