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NCT02666950 · OUTCOME

Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment

WEE1 Inhibitor AZD1775 With or Without Cytarabine in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome · Source last updated 2019-09-06

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 30 days post-treatment

What was measured

The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.

Analysis population: Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.

Groups in this outcome

Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)

Patients receive 20 mg cytarabine (AraC) SC twice daily and 200 mg WEE1 inhibitor (AZD1775) PO daily on days 1-5 and days 8-12 OR receive only 200 mg WEE inhibitor (AZD1775) PO daily on days 1-5, 8-12, 15-19, and 22-26.

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

Analysis denominator · Participants

GroupSource count
Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)3

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
groups
  1. description
    Patients receive 20 mg cytarabine (AraC) SC twice daily and 200 mg WEE1 inhibitor (AZD1775) PO daily on days 1-5 and days 8-12 OR receive only 200 mg WEE inhibitor (AZD1775) PO daily on days 1-5, 8-12, 15-19, and 22-26.
    id
    OG000
    title
    Arm A + Arm C (AZD1775 Combined With AraC OR AZD1775 Only)
param Type
NUMBER
population Description
Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.
reporting Status
POSTED
time Frame
Up to 30 days post-treatment
title
Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice