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NCT00795769 · STUDY IN CONTEXT

Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-stage-iv-e69d3614
nct id
NCT00795769
trial label
Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing Stem Cell Transplant
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00795769
    outcome key
    om-0000
    source section id
    NCT00795769-om-0000
    source outcome index
    0
    endpoint
    Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
    endpoint definition
    Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
    time origin
    Baseline up to 120 minutes
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00795769
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ondansetron Therapy
    regimen
    Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. ondansetron: Given IV survey administration: Correlative studies management of therapy complications: Ondansetron IV
    analyzed count
    49
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00795769-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-stage-iv-e69d3614
    nct id
    NCT00795769
    harm key
    EG000
    source section id
    NCT00795769-ae
    event group key
    EG000
    event group label
    Ondansteron Therapy
    serious affected
    0
    serious at risk
    49
    other affected
    18
    other at risk
    49
    frequency threshold
    5
    collection period
    11 months between August 2008-June 2009
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice