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NCT01445535 · OUTCOME

Number of Participants With Serious and Non-serious Adverse Events

Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas · Source last updated 2021-11-03

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
Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.

What was measured

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Groups in this outcome

Cohort 1 - 3.4 mg/kg

3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

Cohort 2 - 4.8 mg/kg

4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

Cohort 3 - 8.5 mg/kg

8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

Cohort 4 - 15 mg/kg

15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

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

Analysis denominator · Participants

GroupSource count
Cohort 1 - 3.4 mg/kg3
Cohort 2 - 4.8 mg/kg3
Cohort 3 - 8.5 mg/kg3
Cohort 4 - 15 mg/kg6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 - 3.4 mg/kg3Not reportedNot reportedNot reportedNot reported
Cohort 2 - 4.8 mg/kg3Not reportedNot reportedNot reportedNot reported
Cohort 3 - 8.5 mg/kg3Not reportedNot reportedNot reportedNot reported
Cohort 4 - 15 mg/kg5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
groups
  1. description
    3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
    id
    OG000
    title
    Cohort 1 - 3.4 mg/kg
  2. description
    4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
    id
    OG001
    title
    Cohort 2 - 4.8 mg/kg
  3. description
    8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
    id
    OG002
    title
    Cohort 3 - 8.5 mg/kg
  4. description
    15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
    id
    OG003
    title
    Cohort 4 - 15 mg/kg
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Date treatment consent signed until 30 days after removal from study treatment or until off study, whichever comes first, approximately 22 weeks.
title
Number of Participants With Serious and Non-serious Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice