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NCT00524017 · ADVERSE EVENTS

Adverse events

Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract · Source last updated 2020-03-12

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
Arm I (Treatment)

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. cetuximab: given IV

0 / 130 / 130 / 13
Arm II (Control)

Patients receive regular follow-up care

0 / 60 / 60 / 6

Group identifiers: EG000: Arm I (Treatment) · EG001: Arm II (Control)

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
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        13
        description
        Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. cetuximab: given IV
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        13
        serious Num Affected
        0
        serious Num At Risk
        13
        title
        Arm I (Treatment)
      2. deaths Num Affected
        0
        deaths Num At Risk
        6
        description
        Patients receive regular follow-up care
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        6
        serious Num Affected
        0
        serious Num At Risk
        6
        title
        Arm II (Control)
      frequency Threshold
      0

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

      Preserved source evidence · Not medical advice