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NCT00003830 · OUTCOME

Morbidity - Number of Participants With Residual Arm Volume Difference

Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer · Source last updated 2017-12-13

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
before and after surgery (within 30 days of randomization)

What was measured

Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery

Analysis population: Data missing or unknown for some patients.

Groups in this outcome

Arm I:Sentinel Node Resection+Conventional Axillary Dissection

Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.

Arm II: Sentinel Node Resection Followed by Node Examination

Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.

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

Analysis denominator · Participants

GroupSource count
Arm I:Sentinel Node Resection+Conventional Axillary Dissection1136
Arm II: Sentinel Node Resection Followed by Node Examination1151

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I:Sentinel Node Resection+Conventional Axillary Dissection314Not reportedNot reportedNot reportedNot reported
Arm II: Sentinel Node Resection Followed by Node Examination192Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        314
      2. group Id
        OG001
        value
        192
denoms
  1. counts
    1. group Id
      OG000
      value
      1136
    2. group Id
      OG001
      value
      1151
    units
    Participants
description
Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery
groups
  1. description
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    id
    OG000
    title
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
  2. description
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    id
    OG001
    title
    Arm II: Sentinel Node Resection Followed by Node Examination
param Type
COUNT_OF_PARTICIPANTS
population Description
Data missing or unknown for some patients.
reporting Status
POSTED
time Frame
before and after surgery (within 30 days of randomization)
title
Morbidity - Number of Participants With Residual Arm Volume Difference
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice