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NCT00851253 · OUTCOME

Rates of Adverse Events Associated With Treatment

Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer · Source last updated 2018-01-17

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
1 year

What was measured

Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment

Analysis population: One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed.

Groups in this outcome

Group 1 (CK SRS Boost Therapy)

Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

Group 2 (CK SRS Salvage Therapy)

Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses

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

Analysis denominator · Participants

GroupSource count
Group 1 (CK SRS Boost Therapy)1
Group 2 (CK SRS Salvage Therapy)10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 (CK SRS Boost Therapy)1Not reportedNot reportedNot reportedNot reported
Group 2 (CK SRS Salvage Therapy)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment
groups
  1. description
    Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
    id
    OG000
    title
    Group 1 (CK SRS Boost Therapy)
  2. description
    Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly. stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
    id
    OG001
    title
    Group 2 (CK SRS Salvage Therapy)
param Type
COUNT_OF_PARTICIPANTS
population Description
One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed.
reporting Status
POSTED
time Frame
1 year
title
Rates of Adverse Events Associated With Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice