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NCT02488759 · OUTCOME

Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors · Source last updated 2023-11-13

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
From first dose to 30 days post last dose (Up to 2 months)

What was measured

Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort

Analysis population: All treated participants in the neoadjuvant cohort

Groups in this outcome

Neoadjuvant

Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15

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

Analysis denominator · Participants

GroupSource count
Neoadjuvant123

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Neoadjuvant6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    units
    Participants
description
Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort
groups
  1. description
    Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
    id
    OG000
    title
    Neoadjuvant
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants in the neoadjuvant cohort
reporting Status
POSTED
time Frame
From first dose to 30 days post last dose (Up to 2 months)
title
Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice