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NCT00481871 · ADVERSE EVENTS

Adverse events

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies · Source last updated 2020-01-07

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1

Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study

18 / 3535 / 35Not reported / Not reported
Phase 2 - Group B

Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.

13 / 3838 / 38Not reported / Not reported
Phase 2 - Group C

Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.

16 / 3434 / 34Not reported / Not reported

Group identifiers: EG000: Phase 1 · EG001: Phase 2 - Group B · EG002: Phase 2 - Group C

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
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    altered state of consciousness
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    arrhythmia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    cardiac failure congestive
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    cellulitis
  5. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    delirium tremens
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    febrile neutropenia
  7. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    mental status changes
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    myocardial infarction
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    pancytopenia
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    pleural effusion
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
    term
    pneumonia
  12. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    pneumonitis

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
      25
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      34
    term
    fatigue
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      34
    term
    pyrexia
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
    term
    chills
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      34
    term
    oedema peripheral
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    influenza like illness
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    term
    asthenia
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    chest discomfort
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    chest pain
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    term
    non-cardiac chest pain
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      34
    term
    stomatitis
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      34
    term
    nausea
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      34
    term
    diarrhoea
Complete source fields
event Groups
  1. description
    Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
    id
    EG000
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    18
    serious Num At Risk
    35
    title
    Phase 1
  2. description
    Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
    id
    EG001
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    13
    serious Num At Risk
    38
    title
    Phase 2 - Group B
  3. description
    Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
    id
    EG002
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    16
    serious Num At Risk
    34
    title
    Phase 2 - Group C
frequency Threshold
5
other Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      34
    term
    fatigue
  2. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      34
    term
    pyrexia
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      34
    term
    chills
  4. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      34
    term
    oedema peripheral
  5. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    influenza like illness
  6. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    term
    asthenia
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    chest discomfort
  8. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    chest pain
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      34
    term
    non-cardiac chest pain
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      34
    term
    stomatitis
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      34
    term
    nausea
  12. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      34
    term
    diarrhoea
serious Events
  1. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    altered state of consciousness
  2. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    arrhythmia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    cardiac failure congestive
  4. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      34
    term
    cellulitis
  5. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    delirium tremens
  6. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    febrile neutropenia
  7. organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    mental status changes
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    myocardial infarction
  9. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    pancytopenia
  10. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    pleural effusion
  11. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      34
    term
    pneumonia
  12. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      38
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      34
    term
    pneumonitis

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