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NCT02669914 · OUTCOME

Safety of MEDI4736 in Advanced Solid Epithelial-derived Tumor Patients With Brain Metastases as Measured by Number of Participants With Treatment-emergent Adverse Events

MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors · Source last updated 2018-11-06

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
30 days after completion of treatment (estimated to be 7 months)

What was measured

-The severity of AEs will be graded by the investigator according to the CTCAE, Version 4.03

Analysis population: There were not any participants enrolled in Cohort B or Cohort C.

Groups in this outcome

Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids

-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.

Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids

-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.

Cohort C: NSCLC or Non-NSCLC w/Corticosteroids

-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.

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

Analysis denominator · Participants

GroupSource count
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids4
Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids0
Cohort C: NSCLC or Non-NSCLC w/Corticosteroids0

Reported measurements

Grade 1 anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 2 anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 bloating
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 2 constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 2 diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 chills
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 2 fever
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 non-cardiac chest pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 night sweats
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 2 sinusitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 2 lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids2Not reportedNot reportedNot reportedNot reported
Grade 2 weight loss
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 hypercalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 3 hypercalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 arthralgia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 3 paresthesia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 productive cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 2 post nasal drip
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 hyperhidrosis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 pruritus
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Grade 1 hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 bloating
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 constipation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 diarrhea
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 nausea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 chills
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 fever
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 non-cardiac chest pain
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 night sweats
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 sinusitis
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1 lymphocyte count decreased
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
-The severity of AEs will be graded by the investigator according to the CTCAE, Version 4.03
groups
  1. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    OG000
    title
    Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
  2. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    OG001
    title
    Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
  3. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    OG002
    title
    Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
param Type
COUNT_OF_PARTICIPANTS
population Description
There were not any participants enrolled in Cohort B or Cohort C.
reporting Status
POSTED
time Frame
30 days after completion of treatment (estimated to be 7 months)
title
Safety of MEDI4736 in Advanced Solid Epithelial-derived Tumor Patients With Brain Metastases as Measured by Number of Participants With Treatment-emergent Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice