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NCT04798586 · OUTCOME

Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Chemistry Parameters by NCI CTCAE v 5.0

MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma · Source last updated 2024-09-27

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
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)

What was measured

Chemistry parameters that were assessed included: Alanine aminotransferase increased, Alkaline phosphatase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Creatinine increased, Hypercalcemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia. Abnormalities were graded based on CTCAE version 5.0- Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.

Analysis population: SAS included all enrolled participants who received at least 1 dose of study intervention.

Groups in this outcome

Elranatamab

Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).

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

Analysis denominator · Participants

GroupSource count
Elranatamab4

Reported measurements

Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Creatinine increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hypercalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hypernatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hypocalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hypoglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab1Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Alanine aminotransferase increased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Alkaline phosphatase increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Aspartate aminotransferase increased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Blood bilirubin increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Creatinine increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hypercalcemia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hyperkalemia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hypermagnesemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hypernatremia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hypoalbuminemia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hypocalcemia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hypoglycemia
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Chemistry parameters that were assessed included: Alanine aminotransferase increased, Alkaline phosphatase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Creatinine increased, Hypercalcemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia. Abnormalities were graded based on CTCAE version 5.0- Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
groups
  1. description
    Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
    id
    OG000
    title
    Elranatamab
param Type
COUNT_OF_PARTICIPANTS
population Description
SAS included all enrolled participants who received at least 1 dose of study intervention.
reporting Status
POSTED
time Frame
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
title
Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Chemistry Parameters by NCI CTCAE v 5.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice