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NCT04628780 · OUTCOME

Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period

Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors · Source last updated 2024-07-29

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
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)

What was measured

The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.

Analysis population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.

Groups in this outcome

PF-07209960 1 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.

PF-07209960 3 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.

PF-07209960 10 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.

PF-07209960 15 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.

PF-07209960 20 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.

PF-07209960 30 mg SC

Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.

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

Analysis denominator · Participants

GroupSource count
PF-07209960 1 mg SC4
PF-07209960 3 mg SC4
PF-07209960 10 mg SC4
PF-07209960 15 mg SC3
PF-07209960 20 mg SC16
PF-07209960 30 mg SC6

Reported measurements

Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC8Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC5Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC8Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC4Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC9Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC4Not reportedNot reportedNot reportedNot reported
Blood bilirubin increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC8Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC2Not reportedNot reportedNot reportedNot reported
Creatinine increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC8Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC4Not reportedNot reportedNot reportedNot reported
Hypercalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC2Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC1Not reportedNot reportedNot reportedNot reported
Hypermagnesemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC0Not reportedNot reportedNot reportedNot reported
Hypernatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC14Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC5Not reportedNot reportedNot reportedNot reported
Hypocalcemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC0Not reportedNot reportedNot reportedNot reported
Hypoglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC1Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC12Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC1Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC4Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC4Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 10 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC3Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC15Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC5Not 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
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        5
    title
    Alanine aminotransferase increased
  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
        8
      6. group Id
        OG005
        value
        4
    title
    Alkaline phosphatase increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        9
      6. group Id
        OG005
        value
        4
    title
    Aspartate aminotransferase increased
  4. 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
        8
      6. group Id
        OG005
        value
        2
    title
    Blood bilirubin increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        4
    title
    Creatinine increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        2
    title
    Hypercalcemia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
    title
    Hyperkalemia
  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
    Hypermagnesemia
  9. 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Hypernatremia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        14
      6. group Id
        OG005
        value
        5
    title
    Hypoalbuminemia
  11. 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
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
    title
    Hypocalcemia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
    title
    Hypoglycemia
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      16
    6. group Id
      OG005
      value
      6
    units
    Participants
description
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
groups
  1. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
    id
    OG000
    title
    PF-07209960 1 mg SC
  2. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
    id
    OG001
    title
    PF-07209960 3 mg SC
  3. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
    id
    OG002
    title
    PF-07209960 10 mg SC
  4. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
    id
    OG003
    title
    PF-07209960 15 mg SC
  5. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
    id
    OG004
    title
    PF-07209960 20 mg SC
  6. description
    Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
    id
    OG005
    title
    PF-07209960 30 mg SC
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)
title
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice