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NCT01054144 · OUTCOME

Number of Participants With Serious Adverse Events

Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma · Source last updated 2021-10-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Day 1 through Off Study Date, an average of 48 months

What was measured

Number of participants with serious adverse events

Groups in this outcome

Response Adapted Therapy

Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; * Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; * Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; * Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; * Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; * Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; * Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; * Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; * Dose level -1: 20 mg daily on days 1 - 4 every 28 days; * Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; * Dose level -2: 10 mg daily on days 1 - 4 every 28 days; * Dose level -3: Discontinue

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

Analysis denominator · Participants

GroupSource count
Response Adapted Therapy27

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Response Adapted Therapy20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Number of participants with serious adverse events
groups
  1. description
    Lenalidomide, prednisone and dexamethasone as outlined in Intervention Descriptions. Lenalidomide: - Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle; * Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle; * Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle; * Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle; * Dose Level -4: Discontinue Prednisone: - Starting Dose: 100 mg PO days 1-5 every 28 days; * Dose level -1: 50 mg PO days 1-5 of a 28 day cycle; * Dose level -2: 25 mg PO days 1-5 of a 28 day cycle; * Dose level -3: Discontinue Dexamethasone: - Starting Dose: 40 mg daily on days 1 - 4 every 28 days; * Dose level -1: 20 mg daily on days 1 - 4 every 28 days; * Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6; * Dose level -2: 10 mg daily on days 1 - 4 every 28 days; * Dose level -3: Discontinue
    id
    OG000
    title
    Response Adapted Therapy
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 1 through Off Study Date, an average of 48 months
title
Number of Participants With Serious Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice