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NCT04628780 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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

Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).

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

Participants with all-causality TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC4Not reportedNot reportedNot reportedNot reported
PF-07209960 3 mg SC4Not 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 SC16Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC6Not reportedNot reportedNot reportedNot reported
Participants with treatment-related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-07209960 1 mg SC1Not 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 SC14Not reportedNot reportedNot reportedNot reported
PF-07209960 30 mg SC6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        16
      6. group Id
        OG005
        value
        6
    title
    Participants with all-causality TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        14
      6. group Id
        OG005
        value
        6
    title
    Participants with treatment-related TEAEs
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
Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
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 Treatment-Emergent Adverse Events (TEAEs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice