Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03617913 · OUTCOME

Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer · Source last updated 2023-01-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 12 months

What was measured

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients reporting a grade 3+ adverse event regardless of attribution is reported here.

Analysis population: All patients who were registered, received protocol treatment, and were assessed for adverse events were included in this analysis.

Groups in this outcome

Avelumab and Cisplatin IV

Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Avelumab and Cisplatin IV2

Reported measurements

Source class 1

Grade 3+ Adverse Event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab and Cisplatin IV2Not reportedNot reportedNot reportedNot reported

Grade 4+ Adverse Event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab and Cisplatin IV0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      Grade 3+ Adverse Event
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 4+ Adverse Event
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients reporting a grade 3+ adverse event regardless of attribution is reported here.
groups
  1. description
    Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Avelumab and Cisplatin IV
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients who were registered, received protocol treatment, and were assessed for adverse events were included in this analysis.
reporting Status
POSTED
time Frame
Up to 12 months
title
Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice