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NCT02196168 · OUTCOME

Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer · Source last updated 2017-05-03

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

Measure
NUMBER
Unit
adverse events
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug

Groups in this outcome

Arm I (WEE1 Inhibitor MK-1775, Cisplatin)

Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO

Arm II (Placebo, Cisplatin)

Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO

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 I (WEE1 Inhibitor MK-1775, Cisplatin)6
Arm II (Placebo, Cisplatin)0

Reported measurements

Source class 1
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (WEE1 Inhibitor MK-1775, Cisplatin)13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug
groups
  1. description
    Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies WEE1 Inhibitor AZD1775: Given PO
    id
    OG000
    title
    Arm I (WEE1 Inhibitor MK-1775, Cisplatin)
  2. description
    Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1. Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO
    id
    OG001
    title
    Arm II (Placebo, Cisplatin)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 1 year
title
Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
type
SECONDARY
unit Of Measure
adverse events

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

Preserved source evidence · Not medical advice