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NCT00530218 · ADVERSE EVENTS

Adverse events

Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant · Source last updated 2017-12-02

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
Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100.
Other-event reporting threshold
0%

Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Patients With CMV Reactivation Detected

CMV Positive Blood Culture at Day 21 or later -or- CMV Positive PCR Test at Day 21 or later

0 / 3232 / 3219 / 36
Patients Without CMV Reactivation Detected

No CMV Positive Blood Culture at Day 21 or later -and- No CMV Positive PCR Test at Day 21 or later

0 / 00 / 014 / 25

Group identifiers: EG000: Patients With CMV Reactivation Detected · EG001: Patients Without CMV Reactivation Detected

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
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Haptoglobin
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        31
        num At Risk
        32
        num Events
        31
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Hemoglobin
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Hemolysis
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        22
        num At Risk
        32
        num Events
        22
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Leukocytes
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Lymphopenia
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        32
        num Events
        12
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Neutrophils/granulocytes
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        26
        num At Risk
        32
        num Events
        26
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Platelets
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        17
        num At Risk
        32
        num Events
        17
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      pRBCs
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        21
        num At Risk
        32
        num Events
        21
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Acute graft versus host disease
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Chronic graft versus host disease
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Palpitations
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        19
        num At Risk
        32
        num Events
        19
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Supraventricular and nodal arrhythmia
    Complete source fields
    description
    Death was monitored for all participants. Adverse events were assessed for the CMV+ participants, who were treated with intravenous Ganciclovir followed by oral Ganciclovir on detection of CMV reactivation. Among the 36 patients with CMV reactivation, four patients' adverse event data are not available.
    event Groups
    1. deaths Num Affected
      19
      deaths Num At Risk
      36
      description
      CMV Positive Blood Culture at Day 21 or later -or- CMV Positive PCR Test at Day 21 or later
      id
      EG000
      other Num Affected
      32
      other Num At Risk
      32
      serious Num Affected
      0
      serious Num At Risk
      32
      title
      Patients With CMV Reactivation Detected
    2. deaths Num Affected
      14
      deaths Num At Risk
      25
      description
      No CMV Positive Blood Culture at Day 21 or later -and- No CMV Positive PCR Test at Day 21 or later
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Patients Without CMV Reactivation Detected
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Haptoglobin
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        31
        num At Risk
        32
        num Events
        31
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Hemoglobin
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Hemolysis
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        22
        num At Risk
        32
        num Events
        22
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Leukocytes
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Lymphopenia
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        32
        num Events
        12
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Neutrophils/granulocytes
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        26
        num At Risk
        32
        num Events
        26
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Platelets
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        17
        num At Risk
        32
        num Events
        17
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      pRBCs
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        21
        num At Risk
        32
        num Events
        21
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Acute graft versus host disease
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Chronic graft versus host disease
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        32
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Palpitations
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        19
        num At Risk
        32
        num Events
        19
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Supraventricular and nodal arrhythmia
    time Frame
    Death was monitored from Day 0 up to Year 11. Serious and other adverse events were assessed from Day 21 up to Day 100.

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    Preserved source evidence · Not medical advice