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NCT02516241 · OUTCOME

Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

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

Measure
MEAN
Unit
μg/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.

What was measured

Blood samples were collected to determine the serum concentration of tremelimumab.

Analysis population: Pharmacokinetic analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol and had at least one post dose evaluable PK data of durvalumab or tremelimumab

Groups in this outcome

Combination Therapy

MEDI4736 (Durvalumab) + Tremelimumab

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

Analysis denominator · Participants

GroupSource count
Combination Therapy339

Reported measurements

Week 0 - Predose

Analysis denominator · Participants

GroupSource count
Combination Therapy332
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination TherapyNANANot reportedNot reportedweek 0 pre-dose serum concentrations are below the level of detection
Week 0 - Postdose

Analysis denominator · Participants

GroupSource count
Combination Therapy332
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy24.011.5Not reportedNot reportedNot reported
Week 4 - Predose

Analysis denominator · Participants

GroupSource count
Combination Therapy283
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy3.753.18Not reportedNot reportedNot reported
Week 12 - Predose

Analysis denominator · Participants

GroupSource count
Combination Therapy197
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy5.434.01Not reportedNot reportedNot reported
Week 12 - Postdose

Analysis denominator · Participants

GroupSource count
Combination Therapy182
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy28.113.2Not reportedNot reportedNot reported
Follow-up Month 3

Analysis denominator · Participants

GroupSource count
Combination Therapy63
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Combination Therapy0.9431.40Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        week 0 pre-dose serum concentrations are below the level of detection
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        332
      units
      Participants
    title
    Week 0 - Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.5
        value
        24.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        332
      units
      Participants
    title
    Week 0 - Postdose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.18
        value
        3.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        283
      units
      Participants
    title
    Week 4 - Predose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.01
        value
        5.43
    denoms
    1. counts
      1. group Id
        OG000
        value
        197
      units
      Participants
    title
    Week 12 - Predose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.2
        value
        28.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        182
      units
      Participants
    title
    Week 12 - Postdose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.40
        value
        0.943
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Follow-up Month 3
denoms
  1. counts
    1. group Id
      OG000
      value
      339
    units
    Participants
description
Blood samples were collected to determine the serum concentration of tremelimumab.
dispersion Type
Standard Deviation
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    OG000
    title
    Combination Therapy
param Type
MEAN
population Description
Pharmacokinetic analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol and had at least one post dose evaluable PK data of durvalumab or tremelimumab
reporting Status
POSTED
time Frame
Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, pre-dose at week 4, and at follow-up Month 3.
title
Serum Concentrations of Tremelimumab, Pharmacokinetic Analysis Set
type
SECONDARY
unit Of Measure
μg/mL

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Preserved source evidence · Not medical advice