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NCT00623831 · OUTCOME

Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU

A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen · Source last updated 2022-10-25

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Weeks 1 through 6

What was measured

Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.

Analysis population: The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.

Groups in this outcome

Cohort 1 (Safety Analysis Set)

Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.

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

Analysis denominator · Participants

GroupSource count
Cohort 1 (Safety Analysis Set)13

Reported measurements

Pyrogenic Dose: 250 EU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)1Not reportedNot reportedNot reportedNot reported
Pyrogenic Dose: 750 EU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)1Not reportedNot reportedNot reportedNot reported
Pyrogenic Dose: 2250 EU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)1Not reportedNot reportedNot reportedNot reported
Pyrogenic Dose: 20,300 EU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)1Not reportedNot reportedNot reportedNot reported
Pyrogenic Dose: 60,800 EU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)2Not reportedNot reportedNot reportedNot reported
Pyrogenic Dose: 182,000 EU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)2Not reportedNot reportedNot reportedNot reported
Pyrogenic Dose: 547,000 EU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)3Not reportedNot reportedNot reportedNot reported
Desired Pyrogenic Effect Not Observed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)1Not reportedNot reportedNot reportedNot reported
Discontinued Before Pyrogenic Effect Observed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (Safety Analysis Set)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pyrogenic Dose: 250 EU
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pyrogenic Dose: 750 EU
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pyrogenic Dose: 2250 EU
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pyrogenic Dose: 20,300 EU
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Pyrogenic Dose: 60,800 EU
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Pyrogenic Dose: 182,000 EU
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Pyrogenic Dose: 547,000 EU
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Desired Pyrogenic Effect Not Observed
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Discontinued Before Pyrogenic Effect Observed
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Intrasubject dose escalation performed over a dose range of 250 to 547,000 EU until achievement of the desired pyrogenic effects (i.e., body temperature increase to 38°C to 39.5°C). Of note, the median pyrogenic dose was 60,800 EU.
groups
  1. description
    Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
    id
    OG000
    title
    Cohort 1 (Safety Analysis Set)
param Type
NUMBER
population Description
The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Weeks 1 through 6
title
Number of Participants With Pyrogenicity at Each Dose Level Tested in the Intrasubject Dose Escalation Performed Over a Dose Range of 250 to 547,000 EU
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice