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NCT01588951 · ADVERSE EVENTS

Adverse events

Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior · Source last updated 2018-08-14

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
Collected monthly for up to 3.5 years.
Other-event reporting threshold
0%

Only unexpected adverse events, grades III-IV acute GVHD, and chronic GVHD were collected.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
No Leukemia Stem Cells - Consolidation

Without LSC, standard cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.

0 / 20 / 20 / 2
Leukemia Stem Cells - Consolidation

LSC present, randomized to cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.

0 / 20 / 20 / 2
Leukemia Stem Cells - Transplant

LSC present, randomized to allogeneic transplant Allogeneic transplant: Allogeneic stem cell transplant per institutional standards.

0 / 60 / 61 / 6

Group identifiers: EG000: No Leukemia Stem Cells - Consolidation · EG001: Leukemia Stem Cells - Consolidation · EG002: Leukemia Stem Cells - Transplant

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.

      Complete source fields
      description
      Only unexpected adverse events, grades III-IV acute GVHD, and chronic GVHD were collected.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        2
        description
        Without LSC, standard cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        2
        serious Num Affected
        0
        serious Num At Risk
        2
        title
        No Leukemia Stem Cells - Consolidation
      2. deaths Num Affected
        0
        deaths Num At Risk
        2
        description
        LSC present, randomized to cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        2
        serious Num Affected
        0
        serious Num At Risk
        2
        title
        Leukemia Stem Cells - Consolidation
      3. deaths Num Affected
        1
        deaths Num At Risk
        6
        description
        LSC present, randomized to allogeneic transplant Allogeneic transplant: Allogeneic stem cell transplant per institutional standards.
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        6
        serious Num Affected
        0
        serious Num At Risk
        6
        title
        Leukemia Stem Cells - Transplant
      frequency Threshold
      0
      time Frame
      Collected monthly for up to 3.5 years.

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

      Preserved source evidence · Not medical advice