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NCT04628780 · OUTCOME

Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 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 hematology 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

Activated partial thromboplastin time prolonged
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
Anemia
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 SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 15 mg SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC4Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC1Not reportedNot reportedNot reportedNot reported
Fibrinogen decreased
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
Hemoglobin 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 SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC0Not reportedNot reportedNot reportedNot reported
INR 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 SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC2Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC1Not reportedNot reportedNot reportedNot reported
Leukocytosis
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
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC0Not 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 SC16Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC6Not reportedNot reportedNot reportedNot reported
Lymphocyte count 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 SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 20 mg SC0Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC0Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
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 SC1Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC1Not reportedNot reportedNot reportedNot reported
Platelet count decreased
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 SC1Not reportedNot reportedNot reportedNot reported
White blood cell decreased
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 SC1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. 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
    Activated partial thromboplastin time prolonged
  2. 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
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        1
    title
    Anemia
  3. 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
    Fibrinogen decreased
  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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Hemoglobin increased
  5. 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
        1
    title
    INR 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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Leukocytosis
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        16
      6. group Id
        OG005
        value
        6
    title
    Lymphocyte count decreased
  8. 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
    Lymphocyte count increased
  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
        1
      6. group Id
        OG005
        value
        1
    title
    Neutrophil count decreased
  10. 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
        1
    title
    Platelet count decreased
  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
        0
      6. group Id
        OG005
        value
        1
    title
    White blood cell decreased
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 hematology 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 Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice