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NCT01803282 · OUTCOME

Percentage of Participants Experiencing Laboratory Abnormalities

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors · Source last updated 2020-06-02

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days

What was measured

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.

Analysis population: Participants in the Safety Analysis Set were analyzed.

Groups in this outcome

Part A: ADX 200 mg

Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part A: ADX 600 mg

Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part A: ADX 1800 mg

Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: PAC, ADX 800 mg

Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: LAC, ADX 1200 mg

Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: LSC, ADX 1200 mg

Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: EGC, ADX 800 mg

Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg

Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg

Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg

Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg

Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Part B: BRCA, ADX 800 mg

Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

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: ADX 200 mg4
Part A: ADX 600 mg3
Part A: ADX 1800 mg6
Part B: PAC, ADX 800 mg36
Part B: LAC, ADX 1200 mg10
Part B: LSC, ADX 1200 mg10
Part B: EGC, ADX 800 mg40
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg45
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg11
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg44
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg8
Part B: BRCA, ADX 800 mg15

Reported measurements

Any Laboratory abnormalities: Hematology
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: ADX 200 mg0.0Not reportedNot reportedNot reportedNot reported
Part A: ADX 600 mg33.3Not reportedNot reportedNot reportedNot reported
Part A: ADX 1800 mg33.3Not reportedNot reportedNot reportedNot reported
Part B: PAC, ADX 800 mg97.2Not reportedNot reportedNot reportedNot reported
Part B: LAC, ADX 1200 mg90.0Not reportedNot reportedNot reportedNot reported
Part B: LSC, ADX 1200 mg80.0Not reportedNot reportedNot reportedNot reported
Part B: EGC, ADX 800 mg87.5Not reportedNot reportedNot reportedNot reported
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg84.4Not reportedNot reportedNot reportedNot reported
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg90.9Not reportedNot reportedNot reportedNot reported
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg95.5Not reportedNot reportedNot reportedNot reported
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg100.0Not reportedNot reportedNot reportedNot reported
Part B: BRCA, ADX 800 mg86.7Not reportedNot reportedNot reportedNot reported
Any Laboratory abnormalities: Serum Chemistry
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: ADX 200 mg100.0Not reportedNot reportedNot reportedNot reported
Part A: ADX 600 mg66.7Not reportedNot reportedNot reportedNot reported
Part A: ADX 1800 mg83.3Not reportedNot reportedNot reportedNot reported
Part B: PAC, ADX 800 mg88.9Not reportedNot reportedNot reportedNot reported
Part B: LAC, ADX 1200 mg60.0Not reportedNot reportedNot reportedNot reported
Part B: LSC, ADX 1200 mg70.0Not reportedNot reportedNot reportedNot reported
Part B: EGC, ADX 800 mg87.5Not reportedNot reportedNot reportedNot reported
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg95.6Not reportedNot reportedNot reportedNot reported
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg81.8Not reportedNot reportedNot reportedNot reported
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg86.4Not reportedNot reportedNot reportedNot reported
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg87.5Not reportedNot reportedNot reportedNot reported
Part B: BRCA, ADX 800 mg66.7Not reportedNot reportedNot reportedNot reported
Any Laboratory abnormalities: Coagulation
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: ADX 200 mg25.0Not reportedNot reportedNot reportedNot reported
Part A: ADX 600 mg0.0Not reportedNot reportedNot reportedNot reported
Part A: ADX 1800 mg33.3Not reportedNot reportedNot reportedNot reported
Part B: PAC, ADX 800 mg38.9Not reportedNot reportedNot reportedNot reported
Part B: LAC, ADX 1200 mg10.0Not reportedNot reportedNot reportedNot reported
Part B: LSC, ADX 1200 mg10.0Not reportedNot reportedNot reportedNot reported
Part B: EGC, ADX 800 mg35.0Not reportedNot reportedNot reportedNot reported
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg37.8Not reportedNot reportedNot reportedNot reported
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg36.4Not reportedNot reportedNot reportedNot reported
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg45.5Not reportedNot reportedNot reportedNot reported
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg37.5Not reportedNot reportedNot reportedNot reported
Part B: BRCA, ADX 800 mg40.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        33.3
      3. group Id
        OG002
        value
        33.3
      4. group Id
        OG003
        value
        97.2
      5. group Id
        OG004
        value
        90.0
      6. group Id
        OG005
        value
        80.0
      7. group Id
        OG006
        value
        87.5
      8. group Id
        OG007
        value
        84.4
      9. group Id
        OG008
        value
        90.9
      10. group Id
        OG009
        value
        95.5
      11. group Id
        OG010
        value
        100.0
      12. group Id
        OG011
        value
        86.7
    title
    Any Laboratory abnormalities: Hematology
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        66.7
      3. group Id
        OG002
        value
        83.3
      4. group Id
        OG003
        value
        88.9
      5. group Id
        OG004
        value
        60.0
      6. group Id
        OG005
        value
        70.0
      7. group Id
        OG006
        value
        87.5
      8. group Id
        OG007
        value
        95.6
      9. group Id
        OG008
        value
        81.8
      10. group Id
        OG009
        value
        86.4
      11. group Id
        OG010
        value
        87.5
      12. group Id
        OG011
        value
        66.7
    title
    Any Laboratory abnormalities: Serum Chemistry
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25.0
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        33.3
      4. group Id
        OG003
        value
        38.9
      5. group Id
        OG004
        value
        10.0
      6. group Id
        OG005
        value
        10.0
      7. group Id
        OG006
        value
        35.0
      8. group Id
        OG007
        value
        37.8
      9. group Id
        OG008
        value
        36.4
      10. group Id
        OG009
        value
        45.5
      11. group Id
        OG010
        value
        37.5
      12. group Id
        OG011
        value
        40.0
    title
    Any Laboratory abnormalities: Coagulation
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      36
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      40
    8. group Id
      OG007
      value
      45
    9. group Id
      OG008
      value
      11
    10. group Id
      OG009
      value
      44
    11. group Id
      OG010
      value
      8
    12. group Id
      OG011
      value
      15
    units
    Participants
description
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
groups
  1. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG000
    title
    Part A: ADX 200 mg
  2. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG001
    title
    Part A: ADX 600 mg
  3. description
    Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG002
    title
    Part A: ADX 1800 mg
  4. description
    Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG003
    title
    Part B: PAC, ADX 800 mg
  5. description
    Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG004
    title
    Part B: LAC, ADX 1200 mg
  6. description
    Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG005
    title
    Part B: LSC, ADX 1200 mg
  7. description
    Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG006
    title
    Part B: EGC, ADX 800 mg
  8. description
    Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG007
    title
    Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
  9. description
    Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG008
    title
    Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
  10. description
    Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG009
    title
    Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
  11. description
    Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG010
    title
    Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
  12. description
    Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    id
    OG011
    title
    Part B: BRCA, ADX 800 mg
param Type
NUMBER
population Description
Participants in the Safety Analysis Set were analyzed.
reporting Status
POSTED
time Frame
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
title
Percentage of Participants Experiencing Laboratory Abnormalities
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice