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NCT03689192 · OUTCOME

Adverse Events Evaluated by CTCAE 4.0

Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors · Source last updated 2023-02-28

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
0 - 75 weeks

What was measured

Patients were evaluated according to Common Terminology Criteria for Adverse Events (CTCEA). An adverse event (AE) is an abnormal clinical finding. Each participant was assessed from start of treatment until 6 months after the last vaccine.

Groups in this outcome

ARG1-18,19,20 Peptide Vaccine

One ARG1-vaccine every third week for 45 weeks. ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide

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

Analysis denominator · Participants

GroupSource count
ARG1-18,19,20 Peptide Vaccine10

Reported measurements

Source class 1

patients with worst AE grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ARG1-18,19,20 Peptide Vaccine1Not reportedNot reportedNot reportedNot reported

patients with worst AE grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ARG1-18,19,20 Peptide Vaccine7Not reportedNot reportedNot reportedNot reported

patients with worst AE grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ARG1-18,19,20 Peptide Vaccine2Not reportedNot reportedNot reportedNot reported

patients with worst AE grade 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ARG1-18,19,20 Peptide Vaccine0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      patients with worst AE grade 1
    2. measurements
      1. group Id
        OG000
        value
        7
      title
      patients with worst AE grade 2
    3. measurements
      1. group Id
        OG000
        value
        2
      title
      patients with worst AE grade 3
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      patients with worst AE grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Patients were evaluated according to Common Terminology Criteria for Adverse Events (CTCEA). An adverse event (AE) is an abnormal clinical finding. Each participant was assessed from start of treatment until 6 months after the last vaccine.
groups
  1. description
    One ARG1-vaccine every third week for 45 weeks. ARG1-18,19,20: 300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
    id
    OG000
    title
    ARG1-18,19,20 Peptide Vaccine
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
0 - 75 weeks
title
Adverse Events Evaluated by CTCAE 4.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice