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NCT02155647 · OUTCOME

Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)

Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) · Source last updated 2024-03-13

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
Up to 325 weeks

What was measured

The laboratory measurements included hematology, liver function and blood chemistry. Number of participants with clinically significant abnormalities with Grade greater than or equals to (\>=) 3 in laboratory values reported as TEAEs were reported. Clinically Significance was decided by investigator.

Analysis population: Safety analysis set included all participants who received at least 1 dose of study treatment.

Groups in this outcome

Part A: Avelumab

Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.

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

Analysis denominator · Participants

GroupSource count
Part A: Avelumab88

Reported measurements

Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab9Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab18Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
White blood cell count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab2Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab3Not reportedNot reportedNot reportedNot reported
Serum amylase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Cholesterol high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Creatine phosphokinase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Creatinine increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab2Not reportedNot reportedNot reportedNot reported
Chronic kidney disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab3Not reportedNot reportedNot reportedNot reported
Gamma-glutamyltransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab6Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab7Not reportedNot reportedNot reportedNot reported
Hypoglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab2Not reportedNot reportedNot reportedNot reported
Lipase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab4Not reportedNot reportedNot reportedNot reported
Hypermagnesemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab3Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab11Not reportedNot reportedNot reportedNot reported
Hypertriglyceridemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Avelumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Lymphocyte count decreased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Neutrophil count decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Platelet count decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    White blood cell count decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hypoalbuminemia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Alkaline phosphatase increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Alanine aminotransferase increased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Serum amylase increased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Aspartate aminotransferase increased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Blood bilirubin increased
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Cholesterol high
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    units
    Participants
description
The laboratory measurements included hematology, liver function and blood chemistry. Number of participants with clinically significant abnormalities with Grade greater than or equals to (\>=) 3 in laboratory values reported as TEAEs were reported. Clinically Significance was decided by investigator.
groups
  1. description
    Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
    id
    OG000
    title
    Part A: Avelumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Up to 325 weeks
title
Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice