Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03000179 · OUTCOME

Number of Patients With Each Worst-Grade Toxicity

Safety and Efficacy of Avelumab in Small Intestinal Adenocarcinoma · Source last updated 2022-04-14

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
On-study date to 30 days following final dose of study drug, or until the event is resolved, stabilized, or determined to be irreversible by the participating investigator if beyond 30 days.

What was measured

To describe the safety profile of avelumab monotherapy in patients with advanced or metastatic small intestinal adenocarcinoma

Analysis population: all participants

Groups in this outcome

Avelumab Monotherapy

Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks. Avelumab: Avelumab through a vein once 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
Avelumab Monotherapy8

Reported measurements

Anemia, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy2Not reportedNot reportedNot reportedNot reported
Fatigue, Grade2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Infusion related reaction. Grade2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy2Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Anorexia, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased, Grade1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Diarrhea, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Diabetic ketoacidosis, Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Back pain, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Diverticulitis per upper GI series, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Hypokalemia, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Hyponatremia, Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Nausea, Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Rash maculo-papular, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Urticaria, Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab Monotherapy1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Anemia, Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fatigue, Grade2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Infusion related reaction. Grade2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Alanine aminotransferase increased, Grade 1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Alkaline phosphatase increased, Grade 1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anorexia, Grade 2
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Blood bilirubin increased, Grade1
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diarrhea, Grade 1
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diabetic ketoacidosis, Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Back pain, Grade 1
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diverticulitis per upper GI series, Grade 2
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypokalemia, Grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
To describe the safety profile of avelumab monotherapy in patients with advanced or metastatic small intestinal adenocarcinoma
groups
  1. description
    Participants receive avelumab by IV infusion following pretreatment with H1 blockers and acetaminophen once every 2 weeks. Avelumab: Avelumab through a vein once every 2 weeks
    id
    OG000
    title
    Avelumab Monotherapy
param Type
COUNT_OF_PARTICIPANTS
population Description
all participants
reporting Status
POSTED
time Frame
On-study date to 30 days following final dose of study drug, or until the event is resolved, stabilized, or determined to be irreversible by the participating investigator if beyond 30 days.
title
Number of Patients With Each Worst-Grade Toxicity
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice