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NCT00074165 · ADVERSE EVENTS

Adverse events

Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen · Source last updated 2023-07-06

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
During study treatment (1 year).
Other-event reporting threshold
5%

Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Rituximab and Carboplatin

Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2

16 / 171 / 170 / 17

Group identifiers: EG000: Rituximab and Carboplatin

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    Neutropenic Fever
  2. notes
    Hospitalized for unresponsiveness
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Unresponsiveness
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Anemia
  4. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Superficial Epidermolysis
  5. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Neurological Symptoms
  6. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Stroke
  7. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Chemical Meningitis and Seizures
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    Extended Hospitalization
  9. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Hospitalized for Fall
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Death
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Carotid Artery Tear
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Electrolyte Imbalance and Increased Blood Sodium

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Leg Pain
Complete source fields
description
Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    17
    description
    Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    17
    serious Num Affected
    16
    serious Num At Risk
    17
    title
    Rituximab and Carboplatin
frequency Threshold
5
other Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Leg Pain
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    Neutropenic Fever
  2. notes
    Hospitalized for unresponsiveness
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Unresponsiveness
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Anemia
  4. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Superficial Epidermolysis
  5. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Neurological Symptoms
  6. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Stroke
  7. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Chemical Meningitis and Seizures
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
    term
    Extended Hospitalization
  9. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Hospitalized for Fall
  10. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Death
  11. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Carotid Artery Tear
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
    term
    Electrolyte Imbalance and Increased Blood Sodium
time Frame
During study treatment (1 year).

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Preserved source evidence · Not medical advice