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NCT03436732 · OUTCOME

Fraction of Participants With Detectable LMB-100 in Blood After Cycle 4

Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma · Source last updated 2019-11-22

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Day 85

What was measured

Blood is measured for a detectable level of LMB-100 in the blood. LMB-100 is either detectable in the blood or not. A detectable level of LMB-100 in the blood is considered a desirable outcome for the participant. Hence, the reverse is not a considered a desirable outcome for the participant.

Analysis population: This outcome measure was not done because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs.

Groups in this outcome

140 mcg/kg

Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles

100 mcg/kg

Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles

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

Analysis denominator · Participants

GroupSource count
140 mcg/kg0
100 mcg/kg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Blood is measured for a detectable level of LMB-100 in the blood. LMB-100 is either detectable in the blood or not. A detectable level of LMB-100 in the blood is considered a desirable outcome for the participant. Hence, the reverse is not a considered a desirable outcome for the participant.
groups
  1. description
    Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
    id
    OG000
    title
    140 mcg/kg
  2. description
    Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
    id
    OG001
    title
    100 mcg/kg
population Description
This outcome measure was not done because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs.
reporting Status
POSTED
time Frame
Day 85
title
Fraction of Participants With Detectable LMB-100 in Blood After Cycle 4
type
SECONDARY

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

Preserved source evidence · Not medical advice