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NCT03465540 · OUTCOME

Overall Response Rate (ORR) for Participants With Non-Hodgkin's Lymphoma (NHL)

Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies · Source last updated 2023-04-12

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to end of study (a maximum of 48 weeks)

What was measured

ORR was assessed for participants with NHL using response criteria per Lugano Classification. ORR was defined as the percentage of participants who experienced either of the following based on investigator assessment: * partial metabolic response/ PR * complete metabolic response/ CR

Analysis population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Participants with NHL were only enrolled in part 1a, so therefore data is only presented for part 1a. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

Groups in this outcome

Part 1a: Participants With NHL - 80 mg AMG 397

All participants in part 1a with NHL that received 80 mg AMG 397.

Part 1a: Participants With NHL - 160 mg AMG 397

All participants in part 1a with NHL that received 160 mg AMG 397.

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

Analysis denominator · Participants

GroupSource count
Part 1a: Participants With NHL - 80 mg AMG 3971
Part 1a: Participants With NHL - 160 mg AMG 3971

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1a: Participants With NHL - 80 mg AMG 397100.0Not reported2.50100.00Not reported
Part 1a: Participants With NHL - 160 mg AMG 3970.0Not reported0.0097.50Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.50
        upper Limit
        100.00
        value
        100.0
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        97.50
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    units
    Participants
description
ORR was assessed for participants with NHL using response criteria per Lugano Classification. ORR was defined as the percentage of participants who experienced either of the following based on investigator assessment: * partial metabolic response/ PR * complete metabolic response/ CR
dispersion Type
95% Confidence Interval
groups
  1. description
    All participants in part 1a with NHL that received 80 mg AMG 397.
    id
    OG000
    title
    Part 1a: Participants With NHL - 80 mg AMG 397
  2. description
    All participants in part 1a with NHL that received 160 mg AMG 397.
    id
    OG001
    title
    Part 1a: Participants With NHL - 160 mg AMG 397
param Type
NUMBER
population Description
Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Participants with NHL were only enrolled in part 1a, so therefore data is only presented for part 1a. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.
reporting Status
POSTED
time Frame
Up to end of study (a maximum of 48 weeks)
title
Overall Response Rate (ORR) for Participants With Non-Hodgkin's Lymphoma (NHL)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice