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NCT01095757 · ADVERSE EVENTS

Adverse events

Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection · Source last updated 2014-09-29

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Plerixafor + Chemo and G-CSF

Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

0 / 4529 / 45Not reported / Not reported

Group identifiers: EG000: Plerixafor + Chemo and G-CSF

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. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        13
        num At Risk
        45
      term
      Nausea
    2. organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        45
      term
      Bone Pain
    3. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        45
      term
      Diarrhea
    4. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        45
      term
      Fatigue
    5. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        45
      term
      Hypokalemia
    6. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        45
      term
      Lightheadedness
    7. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        45
      term
      Headache
    8. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        26
        num At Risk
        45
      term
      Thrombocytopenia Grade 1/2
    9. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        17
        num At Risk
        45
      term
      Thrombocytopenia Over Grade 2
    10. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        45
      term
      Anemia
    Complete source fields
    event Groups
    1. description
      Patients who receive a combination of Plerixafor, chemotherapy and G-CSF. Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
      id
      EG000
      other Num Affected
      29
      other Num At Risk
      45
      serious Num Affected
      0
      serious Num At Risk
      45
      title
      Plerixafor + Chemo and G-CSF
    frequency Threshold
    0
    other Events
    1. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        13
        num At Risk
        45
      term
      Nausea
    2. organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        45
      term
      Bone Pain
    3. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        45
      term
      Diarrhea
    4. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        45
      term
      Fatigue
    5. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        45
      term
      Hypokalemia
    6. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        45
      term
      Lightheadedness
    7. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        45
      term
      Headache
    8. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        26
        num At Risk
        45
      term
      Thrombocytopenia Grade 1/2
    9. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        17
        num At Risk
        45
      term
      Thrombocytopenia Over Grade 2
    10. organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        45
      term
      Anemia

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    Preserved source evidence · Not medical advice