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NCT02037256 · ADVERSE EVENTS

Adverse events

Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2021-05-10

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
6 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A Treatment (Bortezomib and Filgrastim)

GROUP A Pts. receive filgrastim SC on days 1-8 \& receive bortezomib IV over 3-5 seconds on days 4 \& day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8 bortezomib: Given IV filgrastim: Given SC autologous hematopoietic stem cell transplantation: Under

0 / 66 / 60 / 6
B Treatment (Bortezomib and Filgrastim)

Group B Pts receive filgrastim SC on days 1-8 and receive bortezomib IV over 3-5 seconds on days 4 and day 7 before administraioin of filgrastim. Pts undergo apheresis on days 5-8.

0 / 1717 / 170 / 17

Group identifiers: EG000: A Treatment (Bortezomib and Filgrastim) · EG001: B Treatment (Bortezomib and Filgrastim)

Serious adverse events

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

    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
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Dyspnea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Tachycardia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
        num Events
        2
      term
      Febrile neutropenia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Hypertensive crisis
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Mucositis
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Vomiting
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Hypocalcemia
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Hyperuricemia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Low ionized calcioum
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Hypokalemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        17
        num Events
        4
      term
      Infection 1
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Infection 2
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      6
      description
      GROUP A Pts. receive filgrastim SC on days 1-8 \& receive bortezomib IV over 3-5 seconds on days 4 \& day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8 bortezomib: Given IV filgrastim: Given SC autologous hematopoietic stem cell transplantation: Under
      id
      EG000
      other Num Affected
      6
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      A Treatment (Bortezomib and Filgrastim)
    2. deaths Num Affected
      0
      deaths Num At Risk
      17
      description
      Group B Pts receive filgrastim SC on days 1-8 and receive bortezomib IV over 3-5 seconds on days 4 and day 7 before administraioin of filgrastim. Pts undergo apheresis on days 5-8.
      id
      EG001
      other Num Affected
      17
      other Num At Risk
      17
      serious Num Affected
      0
      serious Num At Risk
      17
      title
      B Treatment (Bortezomib and Filgrastim)
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Dyspnea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Tachycardia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        17
        num Events
        2
      term
      Febrile neutropenia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Hypertensive crisis
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Mucositis
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Vomiting
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Hypocalcemia
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        17
        num Events
        0
      term
      Hyperuricemia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        17
        num Events
        1
      term
      Low ionized calcioum
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Hypokalemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      2. group Id
        EG001
        num Affected
        4
        num At Risk
        17
        num Events
        4
      term
      Infection 1
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        6
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        17
        num Events
        3
      term
      Infection 2
    time Frame
    6 months

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

    Preserved source evidence · Not medical advice