NCT01996865 · OUTCOME

Participants With Grade 3 or Grade 4 Serum Chemistry Parameters

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. · Source last updated 2025-07-10

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 up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

What was measured

Clinical laboratory values in induction period include any laboratory values that are taken after the first dose date of induction therapy through 28 days after the last dose date of therapy. Graded according to the NCI CTCAE version 4.03, except for tumor flare reaction, which is accessed using NCI CTCAE version 3.0. Participants with zero maximum grade are excluded.

Analysis population: All treated participants

Groups in this outcome

Induction Period: Lenalidomide + Rituximab

Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11

Arm A: Lenalidomide + Rituximab

Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.

Arm B: Rituximab

Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29

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
Induction Period: Lenalidomide + Rituximab	500
Arm A: Lenalidomide + Rituximab	134
Arm B: Rituximab	132

Reported measurements

Hypokalemia - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	30	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	8	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	4	Not reported	Not reported	Not reported	Not reported

Hyperkalemia- Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	4	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	0	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	1	Not reported	Not reported	Not reported	Not reported

Hypocalcemia - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	7	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hypercalcemia - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	7	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	0	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	17	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	6	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	2	Not reported	Not reported	Not reported	Not reported

Hypercreatininemia - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	3	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hyperuricemia - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	40	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	13	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	20	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase Increased - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	14	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	3	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase Increased - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	9	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hyperbilirubinemia - Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	5	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	3	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	1	Not reported	Not reported	Not reported	Not reported

Hypokalemia - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	4	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	0	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hyperkalemia- Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	2	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hypocalcemia - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	5	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	5	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	2	Not reported	Not reported	Not reported	Not reported

Hypercalcemia - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	3	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	5	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	1	Not reported	Not reported	Not reported	Not reported

Hypercreatininemia - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	2	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Hyperuricemia - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	9	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	4	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase Increased - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase Increased - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	Not reported	Not reported	Not reported	Not reported

Hyperbilirubinemia - Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Induction Period: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm A: Lenalidomide + Rituximab	1	Not reported	Not reported	Not reported	Not reported
Arm B: Rituximab	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
30
group Id
OG001
value
8
group Id
OG002
value
4
title
Hypokalemia - Grade 3
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
1
title
Hyperkalemia- Grade 3
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
1
group Id
OG002
value
0
title
Hypocalcemia - Grade 3
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
0
group Id
OG002
value
0
title
Hypercalcemia - Grade 3
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
6
group Id
OG002
value
2
title
Hypophosphatemia - Grade 3
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
0
title
Hypercreatininemia - Grade 3
categories
measurements
group Id
OG000
value
40
group Id
OG001
value
13
group Id
OG002
value
20
title
Hyperuricemia - Grade 3
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
3
group Id
OG002
value
0
title
Alanine Aminotransferase Increased - Grade 3
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
1
group Id
OG002
value
0
title
Aspartate Aminotransferase Increased - Grade 3
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
3
group Id
OG002
value
1
title
Hyperbilirubinemia - Grade 3
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
0
title
Hypokalemia - Grade 4
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
0
title
Hyperkalemia- Grade 4

denoms

counts
group Id
OG000
value
500
group Id
OG001
value
134
group Id
OG002
value
132
units
Participants

description

groups

description
Induction Period (12 cycles): participants received lenalidomide 20 mg (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once daily on Days 1 to 21 of every 28-day Cycle for Cycles 1 to 12 AND rituximab 375 mg/m2 every week in Cycle 1 (Days 1, 8, 15, and 22) and Day 1 of every 28-day Cycle for Cycles 3, 5, 7, 9, and 11
id
OG000
title
Induction Period: Lenalidomide + Rituximab
description
Maintenance Period (18 Cycles): lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle for Cycles 13 to 30 AND rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29. Followed by Optional Maintenance Period (up to PD): Lenalidomide 10 mg once daily on Days 1 to 21 of every 28-day Cycle up to PD. This treatment will be at the discretion of the participant and the investigator.
id
OG001
title
Arm A: Lenalidomide + Rituximab
description
Maintenance Period (18 Cycles): participants received rituximab 375 mg/m2 on Day 1 of every 28-day Cycle for Cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
id
OG002
title
Arm B: Rituximab

param Type

COUNT_OF_PARTICIPANTS

population Description

All treated participants

reporting Status

POSTED

time Frame

From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period)

title

Participants With Grade 3 or Grade 4 Serum Chemistry Parameters

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice