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NCT02488759 · OUTCOME

Neoadjuvant: Rate of Surgery Delay

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Day 29

What was measured

Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed \> 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event. Participants with the following diseases will be assessed: 1. HPV positive squamous cell carcinoma of the Head and Neck (SCCHN); 2. HPV negative SCCHN; 3. Cervical Carcinoma; 4. Vaginal/Vulvar Carcinoma; 5. Merkel Cell Carcinoma

Analysis population: All tumor reduction evaluable 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
Neoadjuvant112

Reported measurements

HPV positive SCCHN

Analysis denominator · Participants

GroupSource count
Neoadjuvant25
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neoadjuvant0Not reported013.7Not reported
HPV negative SCCHN

Analysis denominator · Participants

GroupSource count
Neoadjuvant25
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neoadjuvant0Not reported013.7Not reported
Cervical Carcinoma

Analysis denominator · Participants

GroupSource count
Neoadjuvant13
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neoadjuvant7.7Not reported0.236.0Not reported
Vaginal/Vulvar Carcinoma

Analysis denominator · Participants

GroupSource count
Neoadjuvant12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neoadjuvant0Not reported0.026.5Not reported
Merkel Cell Carcinoma

Analysis denominator · Participants

GroupSource count
Neoadjuvant37
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neoadjuvant2.7Not reported0.114.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        13.7
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    HPV positive SCCHN
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        13.7
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    HPV negative SCCHN
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        36.0
        value
        7.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Cervical Carcinoma
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        26.5
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Vaginal/Vulvar Carcinoma
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        14.2
        value
        2.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Merkel Cell Carcinoma
denoms
  1. counts
    1. group Id
      OG000
      value
      112
    units
    Participants
description
Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed \> 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event. Participants with the following diseases will be assessed: 1. HPV positive squamous cell carcinoma of the Head and Neck (SCCHN); 2. HPV negative SCCHN; 3. Cervical Carcinoma; 4. Vaginal/Vulvar Carcinoma; 5. Merkel Cell Carcinoma
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
All tumor reduction evaluable participants in the neoadjuvant cohort
reporting Status
POSTED
time Frame
Day 29
title
Neoadjuvant: Rate of Surgery Delay
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice