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NCT01326923 · ADVERSE EVENTS

Adverse events

Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer · Source last updated 2020-10-09

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
Single Arm

Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Cetuximab: Single arm phase II study of chemotherapy

2 / 70 / 70 / 7

Group identifiers: EG000: Single Arm

Serious 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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    shingles
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    nausea, vomiting, diarrhea
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    hospitalizations

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
      7
      description
      Single arm Phase II Study Induction Chemo then Concurrent Chemoradiotherapy with Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer Cetuximab: Single arm phase II study of chemotherapy
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      7
      serious Num Affected
      2
      serious Num At Risk
      7
      title
      Single Arm
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
        num Events
        1
      term
      shingles
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      nausea, vomiting, diarrhea
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        7
        num Events
        2
      term
      hospitalizations

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

    Preserved source evidence · Not medical advice