A Study of PF-06873600 in People With Cancer | NCT03519178

ID	Type	Description	Link
NCT03519178	Registry Identifier	ClinicalTrials.gov

Status Module

Description Module

Conditions Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Escalation	Experimental	Single Agent Dose Escalation	Drug: PF-06873600
Dose Finding Endocrine Therapy 1 Combination	Experimental	Part 1B PF-06873600 plus Endocrine Therapy 1	Drug: PF-06873600 Drug: Endocrine Therapy 1
Dose Finding Endocrine Therapy 2 Combination	Experimental	Part 1B PF-06873600 plus Endocrine Therapy 2	Drug: PF-06873600 Drug: Endocrine Therapy 2
Dose Expansion Arm A	Experimental	PF-06873600 as a Single Agent	Drug: PF-06873600
Dose Expansion Arm B	Experimental	PF-06873600 as a Single Agent in Various Tumor Types	Drug: PF-06873600
Dose Expansion Arm C	Experimental	PF-06873600 in Combination with Endocrine Therapy 1

Name	Type	Description	Arm Group Labels	Other Names
PF-06873600	Drug	PF-06873600 tablet for oral dosing	Dose Escalation Dose Expansion Arm A Dose Expansion Arm B Dose Expansion Arm C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) - Part 1	DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (28 days) which were attributable to one, the other, or both agents in the combination: Hematologic - grade(G) 4 neutropenia lasting >7 days; Febrile neutropenia defined as an absolute neutrophil count (ANC) <1.0 * 10^9/L with a single temperature of >38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour; G≥3 neutropenia with associated infection; G3 thrombocytopenia with clinically significant bleeding as indicated by ≥ G2 bleeding; G4 thrombocytopenia. Nonhematologic: Confirmed case of Drug Induced Liver Injury (DILI) (Hy's Law); G≥3 AEs that were clinically significant.	Cycle 1 (within 28 days after the first dose of study intervention)
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2	An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment Related AEs were treatment emergent AEs with cause categorized by the investigator as related to study treatment.	Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months
Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2	Severity was graded as NCI CTCAE version 4.03:Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

Secondary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2	The maximum observed concentration of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. The Cmax value was observed directly from data.

Eligibility Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
University Of Alabama at Birmingham

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 3, 2023	Mar 27, 2024

Arm/Group Information

ID	Title	Description
BG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG002	Part 1A PF-06873600 5 mg BID	Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG003	Part 1A PF-06873600 10 mg BID	Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG004	Part 1A PF-06873600 25 mg BID	Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG005	Part 1A PF-06873600 25 mg BID Biomarker	Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG006	Part 1A PF-06873600 35 mg BID	Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG007	Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off	Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG008	Part 1A PF-06873600 50 mg BID	Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG009	Part 1B PF-06873600 25 mg BID Immediate Release (IR)/Fulvestrant Combination	Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.
BG010	Part 1B PF-06873600 25 mg BID IR/Letrozole Combination	Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG011	Part 1C PF-06873600 Modified Release (MR) 20 mg IR 25 mg BID	Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG012	Part 1C PF-06873600 MR 30 mg BID Long Release	Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG013	Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG014	Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
BG015	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0012 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose Limiting Toxicities (DLTs) - Part 1

DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (28 days) which were attributable to one, the other, or both agents in the combination: Hematologic - grade(G) 4 neutropenia lasting >7 days; Febrile neutropenia defined as an absolute neutrophil count (ANC) <1.0 * 10^9/L with a single temperature of >38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour; G≥3 neutropenia with associated infection; G3 thrombocytopenia with clinically significant bleeding as indicated by ≥ G2 bleeding; G4 thrombocytopenia. Nonhematologic: Confirmed case of Drug Induced Liver Injury (DILI) (Hy's Law); G≥3 AEs that were clinically significant.

Analysis population consisted of all enrolled participants who received at least 1 dose of study intervention and who did not have major treatment deviations during the first cycle (ie, evaluable for the maximum tolerated dose [MTD]).

Posted

Count of Participants

Participants

Cycle 1 (within 28 days after the first dose of study intervention)

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG002	Part 1A PF-06873600 5 mg BID	Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG003	Part 1A PF-06873600 10 mg BID	Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG004	Part 1A PF-06873600 25 mg BID	Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG005	Part 1A PF-06873600 25 mg BID Biomarker	Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Units	Counts
Participants	OG0001 OG0012 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) - Part 1 + Part 2

An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after participants' signed informed consent has been obtained. An SAE was an AE resulting in any of the following outcomes: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment Related AEs were treatment emergent AEs with cause categorized by the investigator as related to study treatment.

The safety analysis set included all enrolled participants who received at least 1 dose of study intervention.

Posted

Count of Participants

Participants

Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Primary

Number of Participants With Worst Post-Baseline Hematology Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2

Severity was graded as NCI CTCAE version 4.03:Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

The safety analysis set included all enrolled participants who received at least 1 dose of study intervention. For each laboratory parameter, only participants with evaluable laboratory results were included in the analysis.

Posted

Count of Participants

Participants

Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Primary

Number of Participants With Worst Post-Baseline Chemistry Results Based on Common Terminology Criteria for Adverse Events (CTCAE) Grade: Part 1 + Part 2

Posted

Count of Participants

Participants

Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Primary

Number of Participants With Post-Baseline Vital Sign Abnormalities Meeting Pre-Defined Categorization - Part 1 + Part 2

Pre-defined criteria included: 1) systolic blood pressure (SBP) (mm Hg) minimum (min) value <90; 2) SBP change from baseline (CFB) (mm Hg) maximum (max) decrease >=30 or max increase >=30; 3) diastolic blood pressure (DBP) (mm Hg) min <50; 4) DBP CFB (mm Hg) max decrease >=20 or max increase >=20; 5) supine heart rate (HR) beats per minute (bpm) min <40 or max >120.

The safety analysis set included all enrolled participants who received at least 1 dose of study intervention. For each vital sign measurement, only participants with evaluable vital sign results were included in the analysis.

Posted

Count of Participants

Participants

Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Primary

Number of Participants With Post-Baseline Electrocardiogram (ECG) Changes Meeting Pre-Defined Categorization - Part 1 + Part 2

ECG pre-defined categories for QTc interval adjusted according to Fridericia formula (QTcF) (msec) included: 450 <= max. <=480, 481 <= max. <=500, max >=501; QTcF CFB: 30 < max <=60, max >60; for PR and QRS: PR (msec): max >=300; PR increase from baseline: Baseline >200 and max. >=25% increase, Baseline <=200 and max. >=50% increase; QRS (msec): max >=200; QRS (msec) increase from baseline: Baseline >100 and max. >=25% increase, Baseline <=100 and max. >=50% increase. Categories, with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure.

The safety analysis set included all enrolled participants who received at least 1 dose of study intervention. Only participants with evaluable ECG results were included in the analysis.

Posted

Count of Participants

Participants

Day 1 up to 28 days after the last dose of study intervention, up to approximately 24 months

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Primary

Overall Response Rate (ORR): Part 2

ORR: percentage of participants with confirmed complete response (CR) or partial response (PR). Response evaluation criteria in solid tumors (RECIST) v1.1: a) CR = disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions that had a reduction in short axis to less than (<) 10 millimeter (mm). Disappearance of all non-target lesions. In addition, all lymph nodes assigned a non-target lesion must be non-pathological in size (<10 mm short axis) and b) PR = at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Any radiological assessments taken more than 30 days after the last dose of study therapy or after antineoplastic agents other than study treatments taken by the participants was excluded from the best overall response derivation. Confirmation of CR or PR was to be at least 4 weeks apart from the previous radiological assessment.

For Part 2: the response evaluable population included all participants who received at least 1 dose of study treatment and had baseline disease and at least 1 post baseline disease assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

From the start of the treatment until disease/clinical progression or death or early study discontinuation, whichever happened earlier (approximately up to 24 months)

ID	Title	Description
OG000	Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Maximum Observed Plasma Concentration (Cmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2

The maximum observed concentration of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. The Cmax value was observed directly from data.

The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Geometric Coefficient of Variation was not presented for parameters with participants with evaluable data <3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the geometric mean (geometric coefficient of variation [CV]).

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on Cycle 1 Day 1 (C1D1); Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Secondary

Time to Reach Cmax at Steady State (Tmax) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1 + Part 2

Tmax of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported.

The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.

Posted

Median

Full Range

Hour

Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG002

Secondary

Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

AUClast of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*nanogram per milliliter

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

AUCinf of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*nanogram per milliliter

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Apparent Clearance (CL/F) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

CL/F of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per hour

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Apparent Volume of Distribution (Vz/F) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

Vz/F of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Terminal Half-life (t1/2) of PF-06873600 Following a Single Oral Dose of Study Intervention on Cycle 1 Day 1 - Part 1

t1/2 of PF-06873600 after single dose of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported.

The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Standard deviation was not presented for parameters with participants with evaluable data <3 at that time point. For groups where 2 participants were evaluable for the PK parameter, exact data were presented, instead of the mean (standard deviation).

Posted

Mean

Standard Deviation

Hour

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Steady State Maximum Concentration (Css,Max) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2

Css,max of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Secondary

Time to Maximum Plasma Concentration at Steady State (Tss,Max) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2

Tss,max of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.

Posted

Median

Full Range

Hour

Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Steady State Minimum Plasma Concentration (Css,Min) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1 + Part 2

Css,min of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B and Part 2) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

Posted

Geometric Mean

Geometric Coefficient of Variation

Nanogram per milliliter

Part 1: pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15; Part 2: pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Secondary

Steady-State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,Tau) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

AUCss,tau of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour*nanogram per milliliter

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Secondary

Steady-State Apparent Oral Plasma Clearance (CLss/F) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

CLss/F of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter per hour

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Secondary

Apparent Volume of Distribution at Steady State (Vss/F) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

Vss/F of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID

Secondary

Accumulation Ratio Based on AUC (Rac) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 1

Rac of PF-06873600 after multiple doses of study intervention when given as a single agent (Part 1A and Part 1C), in combination with letrozole, and in combination with fulvestrant (Part 1B) was reported. Multiple-dose PK parameters were not calculated for the modified release selection cohort in Part 1C (ie, the group "Part 1C PF-06873600 MR 20 IR 25 mg BID").

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 12 hours post-dose on C1D15

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Accumulation Ratio Based on Cmax (Observed) (Rac,Cmax) of PF-06873600 Following Multiple Doses of Study Intervention on Cycle 1 Day 15 - Part 2

Rac,cmax of PF-06873600 after multiple doses of study intervention when given as in combination with fulvestrant (Part 2) was reported.

The PK parameter analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

Pre-dose, 1, 2, 4, 6 hours post-dose on C1D15

ID	Title	Description
OG000	Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 2A had received cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

Pharmacodynamic (PD) Biomarker Phospho-retinoblastoma Protein (pRb) in Tumor Tissue in Participants - Part 1 + Part 2

Level of the PD marker, pRb, was analyzed at 2 time points, at screening and at Cycle 2 Day 1. Percentage changes of pRb at Cycle 2 Day 1 from screening (baseline) were calculated.

The biomarker analysis population was all enrolled participants with PD biomarkers evaluated at pre-and/post dose.

Posted

Median

95% Confidence Interval

Percentage of change

Screening and Cycle 2 Day 1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg Twice a Day (BID)	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG002	Part 1A PF-06873600 5 mg BID	Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Secondary

PD Biomarker Ki67 in Tumor Tissue in Participants - Part 1 + Part 2

Level of the PD marker, Ki67, was analyzed at 2 time points, at screening and at Cycle 2 Day 1. Percent changes of pRb at Cycle 2 Day 1 from screening (baseline) were calculated.

The biomarker analysis population was all enrolled participants with PD biomarkers evaluated at pre-and/post dose.

Posted

Median

95% Confidence Interval

Percentage of change

Screening and Cycle 2 Day 1

ID	Title	Description
OG000	Part 1A PF-06873600 1 mg BID	Participants in Part 1A received PF-06873600 1 milligrams (mg) orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.
OG002	Part 1A PF-06873600 5 mg BID	Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1A PF-06873600 1 mg BID	Participants in Part 1A received PF-06873600 1 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	1	0	1	1	1
EG001	Part 1A PF-06873600 2 mg BID	Participants in Part 1A received PF-06873600 2 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	2	1	2	2	2
EG002	Part 1A PF-06873600 5 mg BID	Participants in Part 1A received PF-06873600 5 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	2	0	2	2	2
EG003	Part 1A PF-06873600 10 mg BID	Participants in Part 1A received PF-06873600 10 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	3	0	3	3	3
EG004	Part 1A PF-06873600 25 mg BID	Participants in Part 1A received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	1	9	2	9	9	9
EG005	Part 1A PF-06873600 25 mg BID Biomarker	Participants in Part 1A, with pre and on-treatment tumor and skin biopsies collected, received PF-06873600 25 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	7	0	7	6	7
EG006	Part 1A PF-06873600 35 mg BID	Participants in Part 1A received PF-06873600 35 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	4	1	4	4	4
EG007	Part 1A PF-06873600 35 mg Intermittent Dosing 5 Days on / 2 Days Off	Participants in Part 1A received PF-06873600 35 mg orally intermittent dosing 5 days on/2 days off on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	1	13	4	13	13	13
EG008	Part 1A PF-06873600 50 mg BID	Participants in Part 1A received PF-06873600 50 mg orally BID on a 28-day cycle from Day 1 to Day 28, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	3	10	6	10	10	10
EG009	Part 1B PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or the study was terminated.	1	9	1	9	9	9
EG010	Part 1B PF-06873600 25 mg BID IR/Letrozole Combination	Participants in Part 1B received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus letrozole 2.5 mg once daily as continuous daily dosing, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	7	2	7	7	7
EG011	Part 1C PF-06873600 MR 20 mg IR 25 mg BID	Participants in Part 1C received a single dose of PF-06873600 MR 20 mg orally during the lead-in period on Day -7 and Day -4, followed by IR 25 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	0	5	0	5	5	5
EG012	Part 1C PF-06873600 MR 30 mg BID Long Release	Participants in Part 1C received PF-06873600 MR 30 mg BID starting from Cycle 1 Day 1 orally BID on a 28-day cycle, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	3	6	3	6	6	6
EG013	Part 2A PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 2A had received CDK4/6i treatment before received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	6	45	9	45	45	45
EG014	Part 2C PF-06873600 25 mg BID IR/Fulvestrant Combination	Participants in Part 2C who were naïve to CDK4/6i received PF-06873600 IR 25 mg orally BID on a 28-day cycle from Day 1 to Day 28 plus fulvestrant 500 mg intramuscularly on Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2, and monthly thereafter, until progression of disease, uncontrollable toxicity, a decision by the participant or investigator to discontinue treatment, or study termination.	4	28	5	28	25	28

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG0030 affected3 at risk EG0040 affected9 at risk EG0050 affected7 at risk EG0060 affected4 at risk EG0070 affected13 at risk EG0080 affected10 at risk EG0091 affected9 at risk EG0100 affected7 at risk EG0110 affected5 at risk EG0120 affected6 at risk EG0131 affected45 at risk EG0140 affected28 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Haemolysis	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Gastric stenosis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Disease progression	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Fatigue	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Abdominal infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
COVID-19	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Cystitis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Gastrointestinal bacterial infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Herpes zoster	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pneumonia	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Skin infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Electrocardiogram T wave abnormal	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Confusional state	Psychiatric disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypotension	Vascular disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG0030 affected3 at risk EG0045 affected9 at risk EG0051 affected7 at risk EG0064 affected4 at risk EG0074 affected13 at risk EG0086 affected10 at risk EG0095 affected9 at risk EG0105 affected7 at risk EG0113 affected5 at risk EG0123 affected6 at risk EG01321 affected45 at risk EG01411 affected28 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Palpitations	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Tachycardia	Cardiac disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Asthenopia	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dry eye	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Erythema of eyelid	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Eye pruritus	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Photophobia	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Swelling of eyelid	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Vision blurred	Eye disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0012 affected2 at risk EG0020 affected2 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0022 affected2 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Asthenia	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0021 affected2 at risk EG003
Chest pain	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Chills	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Death	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Early satiety	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Facial pain	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Fatigue	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Localised oedema	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Malaise	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Mucosal inflammation	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Oedema peripheral	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0021 affected2 at risk EG003
Pain	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Peripheral swelling	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pyrexia	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Thirst	General disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
COVID-19	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Candida infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Fungal infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Herpes simplex	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Herpes zoster	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pneumonia	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Sinusitis	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Tooth infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0001 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Amylase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0001 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Blood bilirubin increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Blood creatinine increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Blood pressure decreased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Blood urea increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Blood uric acid increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Lipase increased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Neutrophil count decreased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Platelet count decreased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Weight decreased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
White blood cell count decreased	Investigations	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0001 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0021 affected2 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dizziness	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Headache	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Muscle contractions involuntary	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Nerve compression	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Parosmia	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Peroneal nerve palsy	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Presyncope	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Tremor	Nervous system disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Device breakage	Product Issues	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Depression	Psychiatric disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Urine odour abnormal	Renal and urinary disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Vaginal discharge	Reproductive system and breast disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Chronic cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0011 affected2 at risk EG0020 affected2 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Aortic thrombosis	Vascular disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hot flush	Vascular disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypertension	Vascular disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003
Hypotension	Vascular disorders	MedDRA v27.1	Non-systematic Assessment	EG0000 affected1 at risk EG0010 affected2 at risk EG0020 affected2 at risk EG003

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders
D005184	Fallopian Tube Diseases
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D010051	Ovarian Neoplasms
D005185	Fallopian Tube Neoplasms
D064726	Triple Negative Breast Neoplasms
D018567	Breast Neoplasms, Male
D001943	Breast Neoplasms
D000077216	Carcinoma, Ovarian Epithelial