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NCT01769222 · ADVERSE EVENTS

Adverse events

Ipilimumab and Local Radiation for Selected Solid Tumors · Source last updated 2024-01-24

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
Ipilimumab 25 mg

Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally

0 / 31 / 3Not reported / Not reported
Ipilimumab 25 mg and Radiation Therapy

Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions

0 / 00 / 0Not reported / Not reported

Group identifiers: EG000: Ipilimumab 25 mg · EG001: Ipilimumab 25 mg and Radiation Therapy

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. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE 4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Pain, injection site
    Complete source fields
    event Groups
    1. description
      Participants receive ipilimumab intratumorally on Day 1 Ipilimumab: Given intratumorally
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      Ipilimumab 25 mg
    2. description
      Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions Ipilimumab: Given intratumorally Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Ipilimumab 25 mg and Radiation Therapy
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE 4
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      Pain, injection site

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

    Preserved source evidence · Not medical advice