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NCT04843579 · OUTCOME

Number of Participants With Adverse Events

Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients · Source last updated 2023-10-25

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
Adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. The maximum period that AEs were collected for a participant was 300 days.

What was measured

Adverse events will be determined by Events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The frequency of adverse events will be collected in tabular summary from when a participant consent to study until end of study or patient participant starts a new treatment.

Groups in this outcome

Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)

Selinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone * Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. * Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin * Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. * Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide * Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. * Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle. Selinexor: Given as 60 mg oral capsule Clarithromycin: Given as 500 mg oral capsule Pomalidomide: Given as 4 mg oral capsule Dexamethasone: Given as 40 mg oral capsule

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

Analysis denominator · Participants

GroupSource count
Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Adverse events will be determined by Events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The frequency of adverse events will be collected in tabular summary from when a participant consent to study until end of study or patient participant starts a new treatment.
groups
  1. description
    Selinexor • Given orally at a dose of 60 mg on days 1, 8, and 15 of a 28-day cycle. Dexamethasone * Given orally at a dose of 40 mg on days 1, 8, 15 and 22 of a 28-day cycle. * Subjects will receive a prescription for dexamethasone 4 mg tablets (generic). Clarithromycin * Given orally at a dose of 500 mg twice a day on days 1-28 of a 28-day cycle. * Subjects will receive a prescription for clarithromycin 250 or 500 mg tablets (generic) for oral administration. Pomalidomide * Given orally at a dose of 4 mg daily on days 1-21 of a 28-day cycle. * Subjects will receive a 21-day supply of pomalidomide 1, 2, 3, or 4 mg capsules for oral administration for each treatment cycle. Selinexor: Given as 60 mg oral capsule Clarithromycin: Given as 500 mg oral capsule Pomalidomide: Given as 4 mg oral capsule Dexamethasone: Given as 40 mg oral capsule
    id
    OG000
    title
    Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. The maximum period that AEs were collected for a participant was 300 days.
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice