NCT01938001 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) · Source last updated 2023-02-22

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 to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)

What was measured

TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event. The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death

Analysis population: The safety population was defined as all participants who have received at least one dose of study medication.

Groups in this outcome

Rituximab + Lenalidomide (R^2)

Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.

Rituximab + Placebo

Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.

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
Rituximab + Lenalidomide (R^2)	176
Rituximab + Placebo	180

Reported measurements

Any TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	174	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	173	Not reported	Not reported	Not reported	Not reported

Any TEAE Related to Lenalidomide/Placebo (LEN/PBO)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	159	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	118	Not reported	Not reported	Not reported	Not reported

Any TEAE Related to Rituximab (RIT)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	134	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	105	Not reported	Not reported	Not reported	Not reported

Any Serious TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	45	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	25	Not reported	Not reported	Not reported	Not reported

Any Serious TEAE Related to LEN/PBO

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	23	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	8	Not reported	Not reported	Not reported	Not reported

Any Serious TEAE Related to RIT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	13	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	4	Not reported	Not reported	Not reported	Not reported

Any CTCAE Grade (GR) 3/4 TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	121	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	58	Not reported	Not reported	Not reported	Not reported

Any CTCAE GR 3/4 TEAE Related to LEN/PBO

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	101	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	38	Not reported	Not reported	Not reported	Not reported

Any CTCAE GR 3/4 TEAE Related to RIT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	57	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	20	Not reported	Not reported	Not reported	Not reported

Any GR 5 TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	2	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	2	Not reported	Not reported	Not reported	Not reported

Any TEAE Leading to Dose Reduction LEN/PBO

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	46	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	6	Not reported	Not reported	Not reported	Not reported

Any TEAE Leading to Dose Interruption LEN/PBO

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	113	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	47	Not reported	Not reported	Not reported	Not reported

Any TEAE Leading to Dose Interruption RIT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	59	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	38	Not reported	Not reported	Not reported	Not reported

Any TEAE Leading to Discontinuation of LEN/PBO

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	15	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	9	Not reported	Not reported	Not reported	Not reported

Any TEAE Leading to Discontinuation of RIT

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab + Lenalidomide (R^2)	6	Not reported	Not reported	Not reported	Not reported
Rituximab + Placebo	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
174
group Id
OG001
value
173
title
Any TEAE
categories
measurements
group Id
OG000
value
159
group Id
OG001
value
118
title
Any TEAE Related to Lenalidomide/Placebo (LEN/PBO)
categories
measurements
group Id
OG000
value
134
group Id
OG001
value
105
title
Any TEAE Related to Rituximab (RIT)
categories
measurements
group Id
OG000
value
45
group Id
OG001
value
25
title
Any Serious TEAE
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
8
title
Any Serious TEAE Related to LEN/PBO
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
4
title
Any Serious TEAE Related to RIT
categories
measurements
group Id
OG000
value
121
group Id
OG001
value
58
title
Any CTCAE Grade (GR) 3/4 TEAE
categories
measurements
group Id
OG000
value
101
group Id
OG001
value
38
title
Any CTCAE GR 3/4 TEAE Related to LEN/PBO
categories
measurements
group Id
OG000
value
57
group Id
OG001
value
20
title
Any CTCAE GR 3/4 TEAE Related to RIT
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
title
Any GR 5 TEAE
categories
measurements
group Id
OG000
value
46
group Id
OG001
value
6
title
Any TEAE Leading to Dose Reduction LEN/PBO
categories
measurements
group Id
OG000
value
113
group Id
OG001
value
47
title
Any TEAE Leading to Dose Interruption LEN/PBO

denoms

counts
group Id
OG000
value
176
group Id
OG001
value
180
units
Participants

description

groups

description
Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
id
OG000
title
Rituximab + Lenalidomide (R^2)
description
Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
id
OG001
title
Rituximab + Placebo

param Type

COUNT_OF_PARTICIPANTS

population Description

The safety population was defined as all participants who have received at least one dose of study medication.

reporting Status

POSTED

time Frame

From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months)

title

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice