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NCT04251065 · OUTCOME

Toxicity - Frequency of Relevant Toxicities

Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH · Source last updated 2025-03-28

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
the endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study

What was measured

Frequency of relevant toxicities. Toxicities will be classified according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. This endpoint will be evaluated from the start date of therapy and at any time during therapy and follow-up.

Analysis population: Monitoring planned after the first 5 patients treated.

Groups in this outcome

One Arm

Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.

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

Analysis denominator · Participants

GroupSource count
One Arm5

Reported measurements

Source class 1

Septic shock multi-organ failure

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
One Arm1Not reportedNot reportedNot reportedNot reported

Acute myocardial infraction

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
One Arm1Not reportedNot reportedNot reportedNot reported

Thrombocytopenia

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
One Arm2Not reportedNot reportedNot reportedNot reported

No relevant event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
One Arm1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      Septic shock multi-organ failure
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Acute myocardial infraction
    3. measurements
      1. group Id
        OG000
        value
        2
      title
      Thrombocytopenia
    4. measurements
      1. group Id
        OG000
        value
        1
      title
      No relevant event
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Frequency of relevant toxicities. Toxicities will be classified according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. This endpoint will be evaluated from the start date of therapy and at any time during therapy and follow-up.
groups
  1. description
    Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
    id
    OG000
    title
    One Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
Monitoring planned after the first 5 patients treated.
reporting Status
POSTED
time Frame
the endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
title
Toxicity - Frequency of Relevant Toxicities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice