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NCT01871727 · OUTCOME

Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03)

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma · Source last updated 2024-11-13

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
Cycle 1 (cycle length was 21 days)

What was measured

DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS event was defined as the noted occurrence of at least 2 of the following: hypotension, edema, or serum albumin less than (\<) 3.0 gram per decilitre (g/dL). 3) Clinical visual impairment. 4) Any CTCAE Grade greater than or equal to (\>=) 4 adverse event (AE) that may represent an infusion reaction. 5) Any other Grade 3 or greater toxicity assessed as related to E7777 treatment and which in the opinion of a safety consultancy investigator panel, was a dose-limiting toxicity.

Analysis population: Lead-in analysis set included all participants enrolled in lead-in part.

Groups in this outcome

Lead-In Part: E7777 6 mcg/kg

Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.

Lead-In Part: E7777 9 mcg/kg

Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.

Lead-In Part: E7777 12 mcg/kg

Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.

Lead-In Part: E7777 15 mcg/kg

Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.

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

Analysis denominator · Participants

GroupSource count
Lead-In Part: E7777 6 mcg/kg2
Lead-In Part: E7777 9 mcg/kg8
Lead-In Part: E7777 12 mcg/kg9
Lead-In Part: E7777 15 mcg/kg2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lead-In Part: E7777 6 mcg/kg0Not reportedNot reportedNot reportedNot reported
Lead-In Part: E7777 9 mcg/kg0Not reportedNot reportedNot reportedNot reported
Lead-In Part: E7777 12 mcg/kg0Not reportedNot reportedNot reportedNot reported
Lead-In Part: E7777 15 mcg/kg2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      2
    units
    Participants
description
DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS event was defined as the noted occurrence of at least 2 of the following: hypotension, edema, or serum albumin less than (\<) 3.0 gram per decilitre (g/dL). 3) Clinical visual impairment. 4) Any CTCAE Grade greater than or equal to (\>=) 4 adverse event (AE) that may represent an infusion reaction. 5) Any other Grade 3 or greater toxicity assessed as related to E7777 treatment and which in the opinion of a safety consultancy investigator panel, was a dose-limiting toxicity.
groups
  1. description
    Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    OG000
    title
    Lead-In Part: E7777 6 mcg/kg
  2. description
    Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
    id
    OG001
    title
    Lead-In Part: E7777 9 mcg/kg
  3. description
    Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    OG002
    title
    Lead-In Part: E7777 12 mcg/kg
  4. description
    Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
    id
    OG003
    title
    Lead-In Part: E7777 15 mcg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
Lead-in analysis set included all participants enrolled in lead-in part.
reporting Status
POSTED
time Frame
Cycle 1 (cycle length was 21 days)
title
Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice