NCT01858558 · OUTCOME

Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events

Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma · Source last updated 2020-06-29

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

Measure: NUMBER
Unit: adverse events
Interval / dispersion: Not reported
Time frame: 60 days from aMILs harvest until day 60 after transplant

What was measured

Total number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.

Groups in this outcome

aMIL Arm

Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.

No aMIL

Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL) No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.

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
aMIL Arm	70
No aMIL	31

Reported measurements

Source class 1

Values in adverse events · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
aMIL Arm	129	Not reported	Not reported	Not reported	Not reported
No aMIL	65	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
129
group Id
OG001
value
65

denoms

counts
group Id
OG000
value
70
group Id
OG001
value
31
units
Participants

description

Total number of adverse events grade 3 or higher that occur from MILs harvest through 60 days after transplant.

groups

description
Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
id
OG000
title
aMIL Arm
description
Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL) No aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
id
OG001
title
No aMIL

param Type

NUMBER

reporting Status

POSTED

time Frame

60 days from aMILs harvest until day 60 after transplant

title

Toxicity as Determined by Total Number of Grade 3 or Higher Adverse Events

type

SECONDARY

unit Of Measure

adverse events

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

Preserved source evidence · Not medical advice