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NCT03215030 · OUTCOME

Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2026-01-29

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
Up to 54.3 months in Part 1

What was measured

Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.

Analysis population: SAS:all participants who took ≥1 dose,even if incomplete,of TAK-573.However,clinically significant vital signs measurements data were not collected \& will never be available to present due to an issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in the report form,making data collection impossible.This issue did not impact participant safety or reliability of study data,particularly primary endpoint.

Groups in this outcome

Part 1 (Dose Escalation) Schedule A

Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule B

Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule C

Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule D

Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.

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

Analysis denominator · Participants

GroupSource count
Part 1 (Dose Escalation) Schedule A0
Part 1 (Dose Escalation) Schedule B0
Part 1 (Dose Escalation) Schedule C0
Part 1 (Dose Escalation) Schedule D0

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
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.
groups
  1. description
    Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG000
    title
    Part 1 (Dose Escalation) Schedule A
  2. description
    Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG001
    title
    Part 1 (Dose Escalation) Schedule B
  3. description
    Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
    id
    OG002
    title
    Part 1 (Dose Escalation) Schedule C
  4. description
    Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG003
    title
    Part 1 (Dose Escalation) Schedule D
population Description
SAS:all participants who took ≥1 dose,even if incomplete,of TAK-573.However,clinically significant vital signs measurements data were not collected \& will never be available to present due to an issue with report form used for data collection(identified after trial completion).Assessments of clinical significance were not included in the report form,making data collection impossible.This issue did not impact participant safety or reliability of study data,particularly primary endpoint.
reporting Status
POSTED
time Frame
Up to 54.3 months in Part 1
title
Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements
type
PRIMARY

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

Preserved source evidence · Not medical advice