Trial Outcomes & Findings for A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause (NCT NCT06465368)
NCT ID: NCT06465368
Last Updated: 2026-07-15
Results Overview
CCCA was determined by antigen Kiel 67 (Ki-67) value as decided by Sponsor. Ki-67 was extensively used as a prognostic and predictive biomarker for cancer diagnosis and treatment. Ki-67 expression was measured by immunohistochemistry. Assessment at Day 14 was done in blinded manner by centrally assessed biopsy.
COMPLETED
PHASE2
121 participants
Day 14
2026-07-15
Participant Flow
Participant milestones
| Measure |
PF-07220060 + Letrozole
Participants were randomized and administered PF-07220060, 300 milligrams (mg) (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Treatment (up to 14 Days)
STARTED
|
59
|
62
|
|
Treatment (up to 14 Days)
COMPLETED
|
59
|
61
|
|
Treatment (up to 14 Days)
NOT COMPLETED
|
0
|
1
|
|
Follow-up (up to 35 Days Post Last Dose)
STARTED
|
59
|
62
|
|
Follow-up (up to 35 Days Post Last Dose)
COMPLETED
|
59
|
62
|
|
Follow-up (up to 35 Days Post Last Dose)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
PF-07220060 + Letrozole
Participants were randomized and administered PF-07220060, 300 milligrams (mg) (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Treatment (up to 14 Days)
Other
|
0
|
1
|
Baseline Characteristics
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
Baseline characteristics by cohort
| Measure |
PF-07220060 + Letrozole
n=59 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=62 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 Years
STANDARD_DEVIATION 7.1 • n=20 Participants
|
64.2 Years
STANDARD_DEVIATION 7.4 • n=20 Participants
|
65.3 Years
STANDARD_DEVIATION 7.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=20 Participants
|
62 Participants
n=20 Participants
|
121 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=20 Participants
|
41 Participants
n=20 Participants
|
90 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Ki-67 evaluable analysis set included all participants who were randomized to study intervention, who took at least 1 dose of study intervention, and who had adequate Ki-67 measurements from baseline and Day 14 visits per central laboratory.
CCCA was determined by antigen Kiel 67 (Ki-67) value as decided by Sponsor. Ki-67 was extensively used as a prognostic and predictive biomarker for cancer diagnosis and treatment. Ki-67 expression was measured by immunohistochemistry. Assessment at Day 14 was done in blinded manner by centrally assessed biopsy.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=51 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=56 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Percentage of Participants With Complete Cell Cycle Arrest (CCCA) at Day 14
|
88.2 Percentage of participants
Interval 76.6 to 94.5
|
17.9 Percentage of participants
Interval 10.0 to 29.8
|
SECONDARY outcome
Timeframe: From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)Population: Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was congenital anomaly/birth defect. AEs that occurred on or after the first dose of study treatment and before the end of treatment (35 days after last dose of study treatment or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first) was considered TEAEs. All AEs (SAEs and all other AEs) were considered for evaluation.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=59 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=62 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
29 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)Population: Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was congenital anomaly/birth defect. AEs that occurred on or after the first dose of study treatment and before the end of treatment (35 days after last dose of study treatment or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first) was considered TEAEs.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=59 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=62 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During study treatment (maximum up to 14 days)Population: Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=59 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=62 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Number of Participant With AEs Leading to Any Study Intervention Discontinuation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (the last measurement on or prior to date of the first dose of study intervention if the first dose is not missing, otherwise, on or prior to the randomization date), Day 14 (pre-dose)Population: ctDNA analysis set included all randomized participants who took at least 1 dose with at least 1 ctDNA evaluated at pre or post dose. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable at specified rows.
The methylation-based tumor fraction of a single sample was estimated from methylation signals across targeted regions from the methylation panel, was calibrated using training data including cancer free donors and participants with mixed cancer types. The method included a data-informed differentially methylated region selection targeting regions with high pan cancer signal to noise ratio. This value was an estimate of the proportion of the sample that was tumor derived and expressed as percentage of DNA. ctDNA methylation tumor fraction values were reported in percentage at Baseline and Day 14 were assessed from central laboratory.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=18 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=17 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Circulating Tumor Deoxyribonucleic Acid (ctDNA) Methylation Tumor Fraction Values at Baseline and Day 14
Baseline
|
0.065 Percentage of DNA
Interval 0.007 to 5.171
|
0.047 Percentage of DNA
Interval 0.003 to 0.418
|
|
Circulating Tumor Deoxyribonucleic Acid (ctDNA) Methylation Tumor Fraction Values at Baseline and Day 14
Day 14
|
0.049 Percentage of DNA
Interval 0.008 to 0.397
|
0.036 Percentage of DNA
Interval 0.006 to 0.219
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes before dosing) on Day 14Population: Pharmacokinetic (PK) parameter analysis population: as subset of PK concentration set (all randomized participants, who took at least 1 dose, had at least 1 analyte concentration) including all participants who had PK sample that met PK parameter evaluability criteria. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Since this outcome measure evaluated PK parameter of PF-07220060 only, hence "Letrozole Alone" reporting group was not reported.
Ctrough was pre-dose plasma concentration.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=41 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Plasma Concentration (Ctrough) of PF-07220060 on Day 14
|
669.5 Nanogram per milliliter
Geometric Coefficient of Variation 39
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour before or 1 hour after biopsy on Day 14Population: PK parameter analysis population: as subset of PK concentration set including all participants who had PK sample that met PK parameter evaluability criteria. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. Since this outcome measure evaluated PK parameter of PF-07220060 only, hence "Letrozole Alone" reporting group was not reported.
Cperi-biopsy was plasma concentration at the time of biopsy.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=51 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Plasma Concentration at the Time of Biopsy (Cperi-biopsy) of PF-07220060 on Day 14
|
808.2 Nanogram per milliliter
Geometric Coefficient of Variation 54
|
—
|
SECONDARY outcome
Timeframe: Baseline (the last measurement on or prior to date of the first dose of study intervention if the first dose was not missing, otherwise, on or prior to the randomization date), Day 14 (pre-dose)Population: Ki-67 evaluable analysis set included all participants who were randomized to study intervention, who took at least 1 dose of study intervention, and who had adequate Ki-67 measurements from baseline and Day 14 visits per central laboratory. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Ki-67 was extensively used as a prognostic and predictive biomarker for cancer diagnosis and treatment. Ki-67 expression was measured by immunohistochemistry and expressed as percentage of cells. Assessment at baseline and Day 14 was done in blinded manner by centrally assessed biopsy.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=49 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=54 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Change From Baseline in Antigen Ki-67 at Day 14
|
-30.120 Percentage of cells
Interval -96.79 to 14.66
|
-17.270 Percentage of cells
Interval -56.65 to 14.1
|
SECONDARY outcome
Timeframe: Baseline (the last measurement on or prior to date of the first dose of study intervention if the first dose was not missing, otherwise, on or prior to the randomization date), Day 14 (pre-dose)Population: Ki-67 evaluable analysis set included all participants who were randomized to study intervention, who took at least 1 dose of study intervention, and who had adequate Ki-67 measurements from baseline and Day 14 visits per central laboratory. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Ki-67 was extensively used as a prognostic and predictive biomarker for cancer diagnosis and treatment. Ki-67 expression was measured by immunohistochemistry. Assessment at baseline and Day 14 was done in blinded manner by centrally assessed biopsy. Relative reduction at Day 14 was calculated as:100 \*(1-Ki-67 at Day 14/Ki-67 at Baseline). Relative reduction was expressed in percentage reduction.
Outcome measures
| Measure |
PF-07220060 + Letrozole
n=49 Participants
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=54 Participants
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Relative Reduction (%) of Ki-67 From Baseline at Day 14
|
97.277 Percentage reduction
Interval -33.98 to 99.8
|
72.414 Percentage reduction
Interval -139.88 to 98.28
|
Adverse Events
PF-07220060 + Letrozole
Letrozole Alone
Serious adverse events
| Measure |
PF-07220060 + Letrozole
n=59 participants at risk
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=62 participants at risk
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.7%
1/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
Other adverse events
| Measure |
PF-07220060 + Letrozole
n=59 participants at risk
Participants were randomized and administered PF-07220060, 300 mg (3 tablets of 100 mg each) orally twice daily for 14 consecutive days and letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
Letrozole Alone
n=62 participants at risk
Participants were randomized and administered letrozole 2.5 mg (1 tablet) orally once daily for 14 consecutive days. Participants were followed up to 35 days after the last dose of study intervention.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
18.6%
11/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
1.6%
1/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
13.6%
8/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
4.8%
3/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
10.2%
6/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
4.8%
3/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
5.1%
3/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
4.8%
3/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
4/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
6.5%
4/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
3.4%
2/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
11.3%
7/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
|
Vascular disorders
Hot flush
|
3.4%
2/59 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
9.7%
6/62 • From start of study intervention (Day 1) up to 35 days after the last dose of study intervention or start of subsequent anti-cancer therapy minus 1 day, whichever occurred first (approximately up to 49 days)
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who were randomized to study intervention and who took at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER