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NCT00496860 · OUTCOME

The Maximum-tolerated Dose (MTD) of ALT-801

Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies · Source last updated 2013-07-22

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

Measure
NUMBER
Unit
events
Interval / dispersion
Not reported
Time frame
18 months

What was measured

Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.

Groups in this outcome

ALT-801 0.015 mg/kg/Dose

0.015 mg/kg/dose of ALT-801

ALT-801 0.040 mg/kg/Dose

0.040 mg/kg/dose of ALT-801

ALT-801 0.080 mg/kg/Dose

0.080 mg/kg/dose of ALT-801

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

Analysis denominator · Participants

GroupSource count
ALT-801 0.015 mg/kg/Dose4
ALT-801 0.040 mg/kg/Dose16
ALT-801 0.080 mg/kg/Dose6

Reported measurements

Source class 1
Values in events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALT-801 0.015 mg/kg/Dose0Not reportedNot reportedNot reportedNot reported
ALT-801 0.040 mg/kg/Dose1Not reportedNot reportedNot reportedNot reported
ALT-801 0.080 mg/kg/Dose2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.
groups
  1. description
    0.015 mg/kg/dose of ALT-801
    id
    OG000
    title
    ALT-801 0.015 mg/kg/Dose
  2. description
    0.040 mg/kg/dose of ALT-801
    id
    OG001
    title
    ALT-801 0.040 mg/kg/Dose
  3. description
    0.080 mg/kg/dose of ALT-801
    id
    OG002
    title
    ALT-801 0.080 mg/kg/Dose
param Type
NUMBER
reporting Status
POSTED
time Frame
18 months
title
The Maximum-tolerated Dose (MTD) of ALT-801
type
PRIMARY
unit Of Measure
events

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

Preserved source evidence · Not medical advice