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NCT01344876 · OUTCOME

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

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

DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).

Analysis population: DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs.

Groups in this outcome

OPB-51602 1m/Day

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

OPB-51602 2mg/Day

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

OPB-51602 3mg/Day

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

OPB-51602 4mg/Day

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

OPB-51602 6mg/Day

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

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-51602 1m/Day4
OPB-51602 2mg/Day3
OPB-51602 3mg/Day4
OPB-51602 4mg/Day6
OPB-51602 6mg/Day3

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
OPB-51602 1m/Day0Not reportedNot reportedNot reportedNot reported
OPB-51602 2mg/Day0Not reportedNot reportedNot reportedNot reported
OPB-51602 3mg/Day0Not reportedNot reportedNot reportedNot reported
OPB-51602 4mg/Day0Not reportedNot reportedNot reportedNot reported
OPB-51602 6mg/Day1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      3
    units
    Participants
description
DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).
groups
  1. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    OG000
    title
    OPB-51602 1m/Day
  2. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    OG001
    title
    OPB-51602 2mg/Day
  3. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    OG002
    title
    OPB-51602 3mg/Day
  4. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    OG003
    title
    OPB-51602 4mg/Day
  5. description
    OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
    id
    OG004
    title
    OPB-51602 6mg/Day
param Type
NUMBER
population Description
DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs.
reporting Status
POSTED
time Frame
From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
title
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice