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NCT03582033 · OUTCOME

Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C

A Safety Study of SEA-BCMA in Patients With Multiple Myeloma · Source last updated 2024-12-24

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 the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)

What was measured

An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).

Analysis population: All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.

Groups in this outcome

Part C: SEA-BCMA 1600mg and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part C: SEA-BCMA 800mg and Dexamethasone

Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

Part C: SEA-BCMA 1600 mg and Dexamethasone

Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.

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 C: SEA-BCMA 1600mg and Dexamethasone12
Part C: SEA-BCMA 800mg and Dexamethasone6
Part C: SEA-BCMA 1600 mg and Dexamethasone5

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone11Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone6Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone5Not reportedNot reportedNot reportedNot reported
TESAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone5Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone3Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Treatment Related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone4Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone3Not reportedNot reportedNot reportedNot reported
TEAEs (>= Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: SEA-BCMA 1600mg and Dexamethasone8Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 800mg and Dexamethasone5Not reportedNot reportedNot reportedNot reported
Part C: SEA-BCMA 1600 mg and Dexamethasone3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
    title
    TESAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
    title
    Treatment Related TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        3
    title
    TEAEs (>= Grade 3)
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      5
    units
    Participants
description
An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).
groups
  1. description
    Participants received SEA-BCMA 1600 mg IV q2wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG000
    title
    Part C: SEA-BCMA 1600mg and Dexamethasone
  2. description
    Participants received SEA-BCMA 800 mg IV q1wk on Day 1 and 15 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG001
    title
    Part C: SEA-BCMA 800mg and Dexamethasone
  3. description
    Participants received SEA-BCMA 1600 mg IV q1wk on Day 1,8,15 and 22 of each 28-day cycle, and dexamethasone 40 mg orally or as an IV infusion on Day 1, 8, 15, and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurs first.
    id
    OG002
    title
    Part C: SEA-BCMA 1600 mg and Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants analysis set included all treated participants who received any amount of SEA-BCMA.
reporting Status
POSTED
time Frame
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)
title
Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice