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NCT03937791 · ADVERSE EVENTS

Adverse events

Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions · Source last updated 2021-04-13

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
Date treatment consent signed to date off study, approximately 8 months and 6 days.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells

1x10\^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0. E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10\^11 cells) will be administered intravenously over 20 to 30 minutes.

0 / 11 / 10 / 1

Group identifiers: EG000: Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells

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
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Vaginal pain
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      1x10\^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0. E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10\^11 cells) will be administered intravenously over 20 to 30 minutes.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Vaginal pain
    time Frame
    Date treatment consent signed to date off study, approximately 8 months and 6 days.

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

    Preserved source evidence · Not medical advice