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NCT03576131 · OUTCOME

Number of Participants With >= Grade 3 Laboratory Results

GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors · Source last updated 2023-08-01

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
Day 1 through Day 565 (corresponding to maximum observed duration)

What was measured

Number of participants with laboratory measurements of Grade \>= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.

Analysis population: The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.

Groups in this outcome

Biweekly Regimen (GEN1029 0.1 mg/kg)

Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.

Biweekly Regimen (GEN1029 0.2 mg/kg)

Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 0.3 mg/kg)

Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 1.0 mg/kg)

Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 2.0 mg/kg)

Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 3.0 mg/kg)

Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.

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

Analysis denominator · Participants

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)10
Biweekly Regimen (GEN1029 0.2 mg/kg)7
Biweekly Regimen (GEN1029 0.3 mg/kg)4
Biweekly Regimen (GEN1029 1.0 mg/kg)11
Biweekly Regimen (GEN1029 2.0 mg/kg)7
Biweekly Regimen (GEN1029 3.0 mg/kg)7

Reported measurements

Activated partial thromboplastin time prolonged
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)3Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)2Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Amylase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Asparate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)2Not reportedNot reportedNot reportedNot reported
Bilirubin increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Calcium decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Creatinine increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Gamma-glutamyl transferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)3Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Glucose increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)3Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Hemoglobin decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Lipase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)3Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Lymphocytes decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)3Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Magnesium increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Prothrombin international normalized ratio - increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)2Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Sodium decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)1Not reportedNot reportedNot reportedNot reported
Urate increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Biweekly Regimen (GEN1029 0.1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.2 mg/kg)1Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 0.3 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 1.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 2.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Biweekly Regimen (GEN1029 3.0 mg/kg)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Activated partial thromboplastin time prolonged
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
    title
    Alanine aminotransferase increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    Alkaline phosphatase increased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Amylase increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
    title
    Asparate aminotransferase increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Bilirubin increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Calcium decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Creatinine increased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
    title
    Gamma-glutamyl transferase increased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Glucose increased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Hemoglobin decreased
  12. 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
        0
      6. group Id
        OG005
        value
        0
    title
    Lipase increased
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      7
    units
    Participants
description
Number of participants with laboratory measurements of Grade \>= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.
groups
  1. description
    Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
    id
    OG000
    title
    Biweekly Regimen (GEN1029 0.1 mg/kg)
  2. description
    Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG001
    title
    Biweekly Regimen (GEN1029 0.2 mg/kg)
  3. description
    Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG002
    title
    Biweekly Regimen (GEN1029 0.3 mg/kg)
  4. description
    Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG003
    title
    Biweekly Regimen (GEN1029 1.0 mg/kg)
  5. description
    Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG004
    title
    Biweekly Regimen (GEN1029 2.0 mg/kg)
  6. description
    Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
    id
    OG005
    title
    Biweekly Regimen (GEN1029 3.0 mg/kg)
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.
reporting Status
POSTED
time Frame
Day 1 through Day 565 (corresponding to maximum observed duration)
title
Number of Participants With >= Grade 3 Laboratory Results
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice