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NCT01343368 · ADVERSE EVENTS

Adverse events

Preservation of Ovarian Function After Hematopoietic Cell Transplant · Source last updated 2017-12-05

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
Interventional - Received Leuprolide

Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.

0 / 73 / 7Not reported / Not reported
Observational Arm

Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

0 / 100 / 10Not reported / Not reported

Group identifiers: EG000: Interventional - Received Leuprolide · EG001: Observational Arm

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
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        10
      term
      Hot Flashes
    2. organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        10
      term
      Mood Liability
    Complete source fields
    event Groups
    1. description
      Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
      id
      EG000
      other Num Affected
      3
      other Num At Risk
      7
      serious Num Affected
      0
      serious Num At Risk
      7
      title
      Interventional - Received Leuprolide
    2. description
      Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      10
      serious Num Affected
      0
      serious Num At Risk
      10
      title
      Observational Arm
    frequency Threshold
    0
    other Events
    1. organ System
      Vascular disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        10
      term
      Hot Flashes
    2. organ System
      Psychiatric disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        7
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        10
      term
      Mood Liability

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

    Preserved source evidence · Not medical advice