Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02857426 · ADVERSE EVENTS

Adverse events

A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL) · Source last updated 2021-12-23

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
From first dose to 100 days post last dose (up to approximately 48 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PCNSL Cohort Nivolumab 240 mg (Q2W)

Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.

33 / 4740 / 4732 / 47
PTL Cohort Nivolumab 240 mg (Q2W)

Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.

15 / 1916 / 1913 / 19

Group identifiers: EG000: PCNSL Cohort Nivolumab 240 mg (Q2W) · EG001: PTL Cohort Nivolumab 240 mg (Q2W)

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
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Gait disturbance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Mucosal inflammation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Sudden death

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
    23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Conjunctival hyperaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Eye irritation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Glaucoma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Pupils unequal
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Vision blurred
Complete source fields
event Groups
  1. deaths Num Affected
    32
    deaths Num At Risk
    47
    description
    Nivolumab dosed to participants with relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
    id
    EG000
    other Num Affected
    40
    other Num At Risk
    47
    serious Num Affected
    33
    serious Num At Risk
    47
    title
    PCNSL Cohort Nivolumab 240 mg (Q2W)
  2. deaths Num Affected
    13
    deaths Num At Risk
    19
    description
    Nivolumab dosed to participants with relapsed/refractory Primary Testicular Lymphoma (PTL). Nivolumab 240 mg was given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg was given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab was administered as a 30-minute infusion.
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    19
    serious Num Affected
    15
    serious Num At Risk
    19
    title
    PTL Cohort Nivolumab 240 mg (Q2W)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Vertigo
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Conjunctival hyperaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Eye irritation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      19
    term
    Glaucoma
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Pupils unequal
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Vision blurred
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Dysphagia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Gait disturbance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    General physical health deterioration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Mucosal inflammation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    term
    Pyrexia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    term
    Sudden death
time Frame
From first dose to 100 days post last dose (up to approximately 48 months)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice