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NCT01420679 · OUTCOME

Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities

Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients · Source last updated 2021-11-19

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 of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)

What was measured

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences.

Analysis population: Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.

Groups in this outcome

Pralatrexate Arm

Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.

Observation Arm

Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.

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

Analysis denominator · Participants

GroupSource count
Pralatrexate Arm14
Observation Arm7

Reported measurements

Participants with Any Treatment Emergent AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate Arm14Not reportedNot reportedNot reportedNot reported
Observation Arm6Not reportedNot reportedNot reportedNot reported
Participants with Any Grade 3 - 4 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate Arm8Not reportedNot reportedNot reportedNot reported
Observation Arm2Not reportedNot reportedNot reportedNot reported
Participants with Treatment Emergent AEs Resulting in Deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate Arm1Not reportedNot reportedNot reportedNot reported
Observation Arm0Not reportedNot reportedNot reportedNot reported
Participants with Treatment Emergent SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate Arm4Not reportedNot reportedNot reportedNot reported
Observation Arm0Not reportedNot reportedNot reportedNot reported
Participants with Any SAEs Leading to Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate Arm2Not reportedNot reportedNot reportedNot reported
Observation Arm0Not reportedNot reportedNot reportedNot reported
Hematology:Higher Than Grade 3/4 Lab Abnormalities
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate Arm3Not reportedNot reportedNot reportedNot reported
Observation Arm1Not reportedNot reportedNot reportedNot reported
Chemistry:Higher Than Grade 3/4 Lab Abnormalities
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pralatrexate Arm1Not reportedNot reportedNot reportedNot reported
Observation Arm0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        6
    title
    Participants with Any Treatment Emergent AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        2
    title
    Participants with Any Grade 3 - 4 AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Participants with Treatment Emergent AEs Resulting in Deaths
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    Participants with Treatment Emergent SAEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Participants with Any SAEs Leading to Drug Discontinuation
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    Hematology:Higher Than Grade 3/4 Lab Abnormalities
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Chemistry:Higher Than Grade 3/4 Lab Abnormalities
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      7
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of "Hematology and Chemistry" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences.
groups
  1. description
    Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \[NaCl\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\^2), could be reduced to 20 mg/m\^2 with potential further reductions to 15 and 10 mg/m\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.
    id
    OG000
    title
    Pralatrexate Arm
  2. description
    Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.
    id
    OG001
    title
    Observation Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.
reporting Status
POSTED
time Frame
From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)
title
Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice