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NCT03386513 · OUTCOME

Number of Participants With TEAEs in Participants Who Received IMGN632 As a Single Agent at the RP2D Level (0.045 mg/kg)

Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN · Source last updated 2026-09-04

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
Up to approximately 81 months

What was measured

An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. TEAEs were defined as any new AEs that began or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Analysis population: The safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants treated with IMGN632 at the RP2D.

Groups in this outcome

Schedule A: IMGN632 0.045 mg/kg

Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Schedule A: IMGN632 0.045 mg/kg116

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Schedule A: IMGN632 0.045 mg/kg115Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        115
denoms
  1. counts
    1. group Id
      OG000
      value
      116
    units
    Participants
description
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. TEAEs were defined as any new AEs that began or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
groups
  1. description
    Participants received IMGN632 via IV infusion on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Schedule A: IMGN632 0.045 mg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' = participants treated with IMGN632 at the RP2D.
reporting Status
POSTED
time Frame
Up to approximately 81 months
title
Number of Participants With TEAEs in Participants Who Received IMGN632 As a Single Agent at the RP2D Level (0.045 mg/kg)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice