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NCT01996865 · OUTCOME

Participants Experiencing Adverse Events Related to Vital Signs

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

The number of participants who experienced adverse events related to vital sign measurements

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

GroupSource count
Induction Period: Lenalidomide + Rituximab500
Arm A: Lenalidomide + Rituximab134
Arm B: Rituximab132

Reported measurements

Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Induction Period: Lenalidomide + Rituximab34Not reportedNot reportedNot reportedNot reported
Arm A: Lenalidomide + Rituximab9Not reportedNot reportedNot reportedNot reported
Arm B: Rituximab6Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Induction Period: Lenalidomide + Rituximab22Not reportedNot reportedNot reportedNot reported
Arm A: Lenalidomide + Rituximab4Not reportedNot reportedNot reportedNot reported
Arm B: Rituximab5Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Induction Period: Lenalidomide + Rituximab5Not reportedNot reportedNot reportedNot reported
Arm A: Lenalidomide + Rituximab2Not reportedNot reportedNot reportedNot reported
Arm B: Rituximab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        6
    title
    Hypertension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
    title
    Hypotension
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Hypoxia
denoms
  1. counts
    1. group Id
      OG000
      value
      500
    2. group Id
      OG001
      value
      134
    3. group Id
      OG002
      value
      132
    units
    Participants
description
The number of participants who experienced adverse events related to vital sign measurements
groups
  1. 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
  2. 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
  3. 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 Experiencing Adverse Events Related to Vital Signs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice