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NCT02457793 · OUTCOME

Percentage of Participants With at Least One Adverse Event

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors · Source last updated 2018-11-20

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 15 months

What was measured

An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.

Analysis population: All participants.

Groups in this outcome

Not Assigned

One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.

COB 20 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

COB 40 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

COB 80 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

COB 80 mg + GDC 400 mg

Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.

COB 100 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

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

Analysis denominator · Participants

GroupSource count
Not Assigned1
COB 20 mg + GDC 200 mg5
COB 40 mg + GDC 200 mg3
COB 80 mg + GDC 200 mg5
COB 80 mg + GDC 400 mg4
COB 100 mg + GDC 200 mg6

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Not Assigned100Not reportedNot reportedNot reportedNot reported
COB 20 mg + GDC 200 mg100Not reportedNot reportedNot reportedNot reported
COB 40 mg + GDC 200 mg100Not reportedNot reportedNot reportedNot reported
COB 80 mg + GDC 200 mg100Not reportedNot reportedNot reportedNot reported
COB 80 mg + GDC 400 mg100Not reportedNot reportedNot reportedNot reported
COB 100 mg + GDC 200 mg100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        100
      3. group Id
        OG002
        value
        100
      4. group Id
        OG003
        value
        100
      5. group Id
        OG004
        value
        100
      6. group Id
        OG005
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      6
    units
    Participants
description
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
groups
  1. description
    One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
    id
    OG000
    title
    Not Assigned
  2. description
    Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    OG001
    title
    COB 20 mg + GDC 200 mg
  3. description
    Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    OG002
    title
    COB 40 mg + GDC 200 mg
  4. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    OG003
    title
    COB 80 mg + GDC 200 mg
  5. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
    id
    OG004
    title
    COB 80 mg + GDC 400 mg
  6. description
    Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    OG005
    title
    COB 100 mg + GDC 200 mg
param Type
NUMBER
population Description
All participants.
reporting Status
POSTED
time Frame
Up to 15 months
title
Percentage of Participants With at Least One Adverse Event
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice