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 Hematology 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

Hematology parameters that were assessed included: Anemia, Lymphocyte count decreased, Neutrophil count decreased, Platelet count decreased, White blood cell decreased. Abnormalities were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI 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

Group	Source count
Elranatamab	4

Reported measurements

Anemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Elranatamab	2	Not reported	Not reported	Not reported	Not reported

Lymphocyte count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Elranatamab	4	Not reported	Not reported	Not reported	Not reported

Neutrophil count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Elranatamab	3	Not reported	Not reported	Not reported	Not reported

Platelet count decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Elranatamab	0	Not reported	Not reported	Not reported	Not reported

White blood cell decreased

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Elranatamab	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
title
Anemia
categories
measurements
group Id
OG000
value
4
title
Lymphocyte count decreased
categories
measurements
group Id
OG000
value
3
title
Neutrophil count decreased
categories
measurements
group Id
OG000
value
0
title
Platelet count decreased
categories
measurements
group Id
OG000
value
3
title
White blood cell decreased

denoms

counts
group Id
OG000
value
4
units
Participants

description

groups

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 Hematology 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