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NCT01213472 · OUTCOME

Anti NY-ESO-1 Antibody Concentrations

Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma · Source last updated 2019-10-09

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

Measure
GEOMETRIC_MEAN
Unit
EL.U/mL
Interval / dispersion
95% Confidence Interval
Time frame
Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)

What was measured

Anti-NY-ESO-1 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Analysis population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Groups in this outcome

NY-ESO 1 Group

Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.

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

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group27

Reported measurements

PRE

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group27
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group179.7Not reported100.8320.3Not reported
W4

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group26
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group4134.0Not reported2250.97592.3Not reported
W8

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group21
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group15235.4Not reported9762.123777.2Not reported
W10

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group23
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group22373.0Not reported15198.432934.5Not reported
W12

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group19
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group25626.1Not reported16866.938934.0Not reported
W29

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group13
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group30684.5Not reported22913.541091.2Not reported
W51

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group6
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group23393.6Not reported16574.233018.9Not reported
W75

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group4
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group12661.4Not reported8063.219881.9Not reported
W99

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group3
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group10313.6Not reported3389.631381.9Not reported
W123

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group2
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group5878.2Not reported1460.423659.5Not reported
POST

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group9
Values in EL.U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group17775.8Not reported10390.030411.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        100.8
        upper Limit
        320.3
        value
        179.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    PRE
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2250.9
        upper Limit
        7592.3
        value
        4134.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    W4
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9762.1
        upper Limit
        23777.2
        value
        15235.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    W8
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15198.4
        upper Limit
        32934.5
        value
        22373.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    W10
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16866.9
        upper Limit
        38934.0
        value
        25626.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    W12
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22913.5
        upper Limit
        41091.2
        value
        30684.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    W29
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16574.2
        upper Limit
        33018.9
        value
        23393.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    W51
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8063.2
        upper Limit
        19881.9
        value
        12661.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    W75
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3389.6
        upper Limit
        31381.9
        value
        10313.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    W99
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1460.4
        upper Limit
        23659.5
        value
        5878.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    W123
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10390.0
        upper Limit
        30411.8
        value
        17775.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    POST
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Anti-NY-ESO-1 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
    id
    OG000
    title
    NY-ESO 1 Group
param Type
GEOMETRIC_MEAN
population Description
The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.
reporting Status
POSTED
time Frame
Before treatment (PRE), at 4 (W4), 8 (W8), 10 (W10), 12 (W12), 29 (W29), 51 (W51), 75 (W75), 99 (W99), 123 (W123) weeks of treatment and at the concluding visit, i.e. at Month 49 (POST)
title
Anti NY-ESO-1 Antibody Concentrations
type
SECONDARY
unit Of Measure
EL.U/mL

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Preserved source evidence · Not medical advice