Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01204203 · ADVERSE EVENTS

Adverse events

Pilot Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Malignant Mesothelioma (UAB 0901) · Source last updated 2017-05-24

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
From baseline to 28 months
Other-event reporting threshold
0%

Subjects with either stable disease or objective response continued treatment until disease progression and/or intolerable toxicity at which patients were taken off study. Subjects were monitored for toxicity using NCI CTAE v3.0 Criteria. Dose adjustment was allowed per standard guidelines for zoledronic acid for decreased creatinine clearance. Patients who completed at least one treatment cycle were included in data analysis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Zoledronic Acid (Zometa)

Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.

0 / 80 / 80 / 8

Group identifiers: EG000: Zoledronic Acid (Zometa)

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
      description
      Subjects with either stable disease or objective response continued treatment until disease progression and/or intolerable toxicity at which patients were taken off study. Subjects were monitored for toxicity using NCI CTAE v3.0 Criteria. Dose adjustment was allowed per standard guidelines for zoledronic acid for decreased creatinine clearance. Patients who completed at least one treatment cycle were included in data analysis.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        8
        description
        Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        8
        serious Num Affected
        0
        serious Num At Risk
        8
        title
        Zoledronic Acid (Zometa)
      frequency Threshold
      0
      time Frame
      From baseline to 28 months

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

      Preserved source evidence · Not medical advice