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NCT02711345 · OUTCOME

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers. · Source last updated 2019-09-19

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 2.8 years

What was measured

An adverse events is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. A SAE is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.

Analysis population: The safety set included all participants who had received at least one dose of LTT462.

Groups in this outcome

LTT462 45 mg QD

Participants received 45 mg LTT462 QD as oral capsules.

LTT462 100 mg QD

Participants received 100 mg LTT462 QD as oral capsules.

LTT462 150 mg QD

Participants received 150 mg LTT462 QD as oral capsules.

LTT462 200 mg QD

Participants received 200 mg LTT462 QD as oral capsules.

LTT462 300 mg QD

Participants received 300 mg LTT462 QD as oral capsules.

LTT462 400 mg QD

Participants received 400 mg LTT462 QD as oral capsules.

LTT462 450 mg QD

Participants received 450 mg LTT462 QD as oral capsules.

LTT462 600 mg QD

Participants received 600 mg LTT462 QD as oral capsules.

LTT462 150 mg BID

Participants received 150 mg LTT462 BID as oral capsules.

LTT462 200 mg BID

Participants received 200 mg LTT462 BID as oral capsules.

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

Analysis denominator · Participants

GroupSource count
LTT462 45 mg QD2
LTT462 100 mg QD3
LTT462 150 mg QD6
LTT462 200 mg QD4
LTT462 300 mg QD8
LTT462 400 mg QD6
LTT462 450 mg QD12
LTT462 600 mg QD6
LTT462 150 mg BID6
LTT462 200 mg BID12

Reported measurements

AEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD2Not reportedNot reportedNot reportedNot reported
LTT462 100 mg QD3Not reportedNot reportedNot reportedNot reported
LTT462 150 mg QD6Not reportedNot reportedNot reportedNot reported
LTT462 200 mg QD4Not reportedNot reportedNot reportedNot reported
LTT462 300 mg QD8Not reportedNot reportedNot reportedNot reported
LTT462 400 mg QD6Not reportedNot reportedNot reportedNot reported
LTT462 450 mg QD12Not reportedNot reportedNot reportedNot reported
LTT462 600 mg QD5Not reportedNot reportedNot reportedNot reported
LTT462 150 mg BID6Not reportedNot reportedNot reportedNot reported
LTT462 200 mg BID12Not reportedNot reportedNot reportedNot reported
SAEs
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD1Not reportedNot reportedNot reportedNot reported
LTT462 100 mg QD0Not reportedNot reportedNot reportedNot reported
LTT462 150 mg QD3Not reportedNot reportedNot reportedNot reported
LTT462 200 mg QD1Not reportedNot reportedNot reportedNot reported
LTT462 300 mg QD5Not reportedNot reportedNot reportedNot reported
LTT462 400 mg QD1Not reportedNot reportedNot reportedNot reported
LTT462 450 mg QD8Not reportedNot reportedNot reportedNot reported
LTT462 600 mg QD4Not reportedNot reportedNot reportedNot reported
LTT462 150 mg BID3Not reportedNot reportedNot reportedNot reported
LTT462 200 mg BID5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        6
      10. group Id
        OG009
        value
        12
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        8
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        5
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      12
    8. group Id
      OG007
      value
      6
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      12
    units
    Participants
description
An adverse events is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. A SAE is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.
groups
  1. description
    Participants received 45 mg LTT462 QD as oral capsules.
    id
    OG000
    title
    LTT462 45 mg QD
  2. description
    Participants received 100 mg LTT462 QD as oral capsules.
    id
    OG001
    title
    LTT462 100 mg QD
  3. description
    Participants received 150 mg LTT462 QD as oral capsules.
    id
    OG002
    title
    LTT462 150 mg QD
  4. description
    Participants received 200 mg LTT462 QD as oral capsules.
    id
    OG003
    title
    LTT462 200 mg QD
  5. description
    Participants received 300 mg LTT462 QD as oral capsules.
    id
    OG004
    title
    LTT462 300 mg QD
  6. description
    Participants received 400 mg LTT462 QD as oral capsules.
    id
    OG005
    title
    LTT462 400 mg QD
  7. description
    Participants received 450 mg LTT462 QD as oral capsules.
    id
    OG006
    title
    LTT462 450 mg QD
  8. description
    Participants received 600 mg LTT462 QD as oral capsules.
    id
    OG007
    title
    LTT462 600 mg QD
  9. description
    Participants received 150 mg LTT462 BID as oral capsules.
    id
    OG008
    title
    LTT462 150 mg BID
  10. description
    Participants received 200 mg LTT462 BID as oral capsules.
    id
    OG009
    title
    LTT462 200 mg BID
param Type
NUMBER
population Description
The safety set included all participants who had received at least one dose of LTT462.
reporting Status
POSTED
time Frame
Up to 2.8 years
title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice