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NCT01344876 · OUTCOME

Subjects With Treatment Emergent Adverse Events

Phase I Study of OPB-51602 in Patients With Hematologic Malignancies · Source last updated 2015-06-08

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)

What was measured

Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.

Analysis population: Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.

Groups in this outcome

OPB-51602

OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle OPB-51602: once daily during the treatment period

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

Analysis denominator · Participants

GroupSource count
OPB-5160220

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
OPB-5160220Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
groups
  1. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle OPB-51602: once daily during the treatment period
    id
    OG000
    title
    OPB-51602
param Type
NUMBER
population Description
Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.
reporting Status
POSTED
time Frame
From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
title
Subjects With Treatment Emergent Adverse Events
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice