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NCT00591305 · ADVERSE EVENTS

Adverse events

New Therapy of Laryngeal Papilloma In Children · Source last updated 2017-05-18

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
3 months after surgery
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PDL+DIM Pill

once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects

0 / 10 / 10 / 1
PDL+Placebo Pill

once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects

0 / 00 / 00 / 0

Group identifiers: EG000: PDL+DIM Pill · EG001: PDL+Placebo Pill

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
        1
        description
        once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        1
        serious Num Affected
        0
        serious Num At Risk
        1
        title
        PDL+DIM Pill
      2. deaths Num Affected
        0
        deaths Num At Risk
        0
        description
        once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        PDL+Placebo Pill
      frequency Threshold
      0
      time Frame
      3 months after surgery

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

      Preserved source evidence · Not medical advice