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NCT03075553 · OUTCOME

Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events

Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma · Source last updated 2020-04-21

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
Up to 390 days

What was measured

The number of participants who experienced at least one grade 3 or higher adverse events are summarized below.

Groups in this outcome

Treatment (Nivolumab)

Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment (Nivolumab)12

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Nivolumab)6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The number of participants who experienced at least one grade 3 or higher adverse events are summarized below.
groups
  1. description
    Patients receive 240 mg nivolumab IV over 60 minutes on day 1. Treatment repeats every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, complete response, or partial response receive 480 mg nivolumab IV over 60 minutes on day 1 of cycle 9. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Nivolumab)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 390 days
title
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice