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NCT01213472 · OUTCOME

Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
During the study treatment period (maximum duration = 49 months).

What was measured

A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs were considered as medically significant and were therefore notified as SAE.

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 Group33

Reported measurements

Any event, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group0Not reportedNot reportedNot reportedNot reported
Any event, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group1Not reportedNot reportedNot reportedNot reported
Any event, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group2Not reportedNot reportedNot reportedNot reported
Any event, Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group0Not reportedNot reportedNot reportedNot reported
Any event, Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any event, Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Any event, Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Any event, Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any event, Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Any event, Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study patient, is a grade 4 AE according to the Common Terminology Criteria for Adverse Events (CTCAE, v 4.0), in addition, in this study, Grade 3 or higher pIMDs were considered as medically significant and were therefore notified as SAE.
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
COUNT_OF_PARTICIPANTS
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
During the study treatment period (maximum duration = 49 months).
title
Number of Patients With Serious Adverse Events (SAEs) by Maximum Grade
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice