A Study of Abemaciclib (LY2835219) With Abiraterone in Me... | NCT05288166

ID	Type	Description	Link
I3Y-MC-JPEG	Other Identifier	Eli Lilly and Company
2022-500461-28-06	Other Identifier	EU Trial Number

Label	Type	Description	Intervention Names
Abemaciclib	Experimental	Participants received 200 milligram (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	Drug: Abemaciclib Drug: Abiraterone Drug: Prednisone or Prednisolone
Placebo	Active Comparator	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	Drug: Abiraterone Drug: Prednisone or Prednisolone Drug: Placebo for Abemaciclib

Name	Type	Description	Arm Group Labels	Other Names
Abemaciclib	Drug	Administered orally.	Abemaciclib	LY2835219

Measure	Description	Time Frame
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator	The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.	From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)

Measure	Description	Time Frame
Radiographic Progression-Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR)	The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Oncology Associates, P.C. - HOPE		Prescott	Arizona	86301	United States
Arizona Oncology Associates, P.C. - HOPE

Label	URL
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)	View source

ID	Title	Description
FG000	Abemaciclib	Participants received 200 milligram (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 6, 2024	Feb 10, 2025

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

Radiographic Progression-Free Survival (rPFS) Assessed by Investigator

The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.

All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 385," "Placebo = 389."

Posted

Median

95% Confidence Interval

Months

From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants	OG000463 OG001462

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Due to high number of censored participants, the median, upper and lower limit 95% confidence interval were not estimable. OG001NA(NA to NA)Due to high number of censored participants, the median, upper and lower limit 95% confidence interval were not estimable.

Secondary

Radiographic Progression-Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR)

All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 435," "Placebo = 440"

Posted

Median

95% Confidence Interval

Months

From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Castration-resistant Prostate Cancer (CRPC)-Free Survival

CRPC-free survival is defined as the time from the date of randomization to the earliest date of castration resistance, as demonstrated by any of the following (whichever occurs earliest):

Confirmed prostate-specific antigen (PSA) progression with serum testosterone ≤50 nanogram/deciliter (ng/dL) (≤1.73 nanomoles per liter(nmol/L)).

Investigator-assessed radiographic progression with serum testosterone ≤50 ng/dL (≤1.73 nmol/L).

Death from any cause.

All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 363," "Placebo = 360."

Posted

Median

95% Confidence Interval

Months

Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 ng/dL; or death from any cause (up to 22 months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Overall Survival (OS)

The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.

All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 416," "Placebo = 430."

Posted

Median

95% Confidence Interval

Months

From Date of Randomization to Date of Death Due to Any Cause (Up to 22 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Time to Pain Progression

All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 368," "Placebo = 343"

Posted

Median

95% Confidence Interval

Months

Randomization to pain progression (up to 22 months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants

Secondary

Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Physical Well-Being Subscale

Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Physical Well-Being subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Physical well-being subscale score ranges from 0 to 28 with high score indicating better quality of life.

All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 328," "Placebo = 394"

Posted

Median

95% Confidence Interval

Months

Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Time to Deterioration in Health-Related Quality of Life (HRQoL) Measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) - Prostate Cancer Subscale

Time to deterioration in health-related quality of life (HRQoL) was defined as the time from randomization to the date of the first clinically meaningful HRQoL deterioration on 2 consecutive measurements. HRQoL evaluation was performed using the FACT-P questionnaire. Prostate Cancer Subscale is a subsection of FACT-P questionnaire. FACT-P consists of 39 core items to assess health related quality of life in participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate cancer subscale (12 items). Each item is rated from 0 (Not at all) to 4 (Very much) and combined to produce subscale scores. FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to 156 with higher score indicating better quality of life. Prostate cancer subscale score ranges from 0 to 48 with high score indicating better quality of life.

All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 329," "Placebo = 365."

Posted

Median

95% Confidence Interval

Months

Randomization to the date of the first clinically meaningful HRQoL deterioration (up to 22 months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib

Maximum plasma concentration at steady state (Cmax,ss) of abemaciclib was evaluated.

All randomized participants who received at least one dose of study drug had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

Predose on Cycle 1 Day 1, Predose and Predose on Cycle 2 Day 1 and Predose on Cycle 3 Day 1 (28 Day Cycles)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00010 events9 affected460 at risk EG0010 events0 affected460 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0010 events0 affected460 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected460 at risk EG0010 events0 affected460 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected460 at risk EG0012 events2 affected460 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected460 at risk EG0012 events2 affected460 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Left ventricular failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected460 at risk EG0014 events4 affected460 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Cataract	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected460 at risk EG0010 events0 affected460 at risk
Retinal detachment	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected460 at risk EG0010 events0 affected460 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0012 events2 affected460 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0012 events2 affected460 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0013 events3 affected460 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0012 events2 affected460 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Splenic artery aneurysm	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0010 events0 affected460 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected460 at risk EG0011 events1 affected460 at risk
Chest discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Death	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected460 at risk EG0011 events1 affected460 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0012 events2 affected460 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Stenosis	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Appendicitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Appendicitis perforated	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected460 at risk EG0011 events1 affected460 at risk
Complicated appendicitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected460 at risk EG0014 events3 affected460 at risk
Covid-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Endocarditis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected460 at risk EG0010 events0 affected460 at risk
Lip infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Oral candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00020 events19 affected460 at risk EG0014 events4 affected460 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Pneumonia viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected460 at risk EG0012 events2 affected460 at risk
Septic shock	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00013 events11 affected460 at risk EG0013 events3 affected460 at risk
Urosepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected460 at risk EG0011 events1 affected460 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected460 at risk EG0010 events0 affected460 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0010 events0 affected460 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0011 events1 affected460 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0010 events0 affected460 at risk
Troponin t increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0010 events0 affected460 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0012 events2 affected460 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected460 at risk EG0014 events3 affected460 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Perivascular epithelioid cell tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0012 events2 affected460 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Loss of consciousness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Peripheral paralysis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected460 at risk EG0010 events0 affected460 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Confusional state	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0012 events2 affected460 at risk
Delirium	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0012 events2 affected460 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected460 at risk EG0010 events0 affected460 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0011 events1 affected460 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected460 at risk EG0010 events0 affected460 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0012 events2 affected460 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected460 at risk EG0010 events0 affected460 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected460 at risk EG0010 events0 affected460 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0011 events1 affected460 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0011 events1 affected460 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected460 at risk EG0011 events1 affected460 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected460 at risk EG0010 events0 affected460 at risk
Extrinsic iliac vein compression	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected460 at risk EG0010 events0 affected460 at risk
Phlebitis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Varicose vein	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected460 at risk EG0011 events1 affected460 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000317 events252 affected460 at risk EG00172 events58 affected460 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000259 events126 affected460 at risk EG00115 events10 affected460 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00084 events45 affected460 at risk EG00129 events20 affected460 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000395 events217 affected460 at risk EG00118 events13 affected460 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000198 events125 affected460 at risk EG00120 events14 affected460 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00084 events73 affected460 at risk EG00140 events34 affected460 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00053 events45 affected460 at risk EG00151 events43 affected460 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000636 events301 affected460 at risk EG00176 events62 affected460 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000150 events116 affected460 at risk EG00148 events41 affected460 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00092 events65 affected460 at risk EG00125 events22 affected460 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG000223 events178 affected460 at risk EG001102 events91 affected460 at risk
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG00029 events24 affected460 at risk EG00110 events8 affected460 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG00082 events66 affected460 at risk EG00140 events31 affected460 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG00045 events38 affected460 at risk EG00116 events14 affected460 at risk
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00029 events28 affected460 at risk EG00121 events21 affected460 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00056 events45 affected460 at risk EG00127 events22 affected460 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00082 events63 affected460 at risk EG00193 events77 affected460 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00068 events53 affected460 at risk EG00187 events70 affected460 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00030 events26 affected460 at risk EG00115 events15 affected460 at risk
Blood bilirubin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00035 events25 affected460 at risk EG00153 events28 affected460 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG000193 events130 affected460 at risk EG00122 events17 affected460 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00037 events32 affected460 at risk EG0017 events7 affected460 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00099 events87 affected460 at risk EG00110 events9 affected460 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00037 events25 affected460 at risk EG00125 events20 affected460 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00019 events14 affected460 at risk EG00135 events31 affected460 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00062 events50 affected460 at risk EG00166 events47 affected460 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00043 events25 affected460 at risk EG00123 events14 affected460 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG000240 events133 affected460 at risk EG001106 events63 affected460 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00036 events33 affected460 at risk EG00147 events39 affected460 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00027 events27 affected460 at risk EG00143 events34 affected460 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00021 events17 affected460 at risk EG00131 events25 affected460 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00043 events35 affected460 at risk EG00126 events24 affected460 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00041 events37 affected460 at risk EG0014 events4 affected460 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00040 events36 affected460 at risk EG00141 events34 affected460 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00026 events24 affected460 at risk EG00127 events19 affected460 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00047 events40 affected460 at risk EG00143 events35 affected460 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00026 events24 affected460 at risk EG00117 events15 affected460 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00046 events42 affected460 at risk EG00119 events18 affected460 at risk
Hot flush	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00074 events69 affected460 at risk EG001106 events98 affected460 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00066 events52 affected460 at risk EG00176 events69 affected460 at risk

ID	Term
D011471	Prostatic Neoplasms
D009362	Neoplasm Metastasis
D014565	Urogenital Neoplasms

ID	Term
D005834	Genital Neoplasms, Male
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols

ID	Title	Description
BG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
BG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	47	460	145	460	445	460
EG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	32	460	68	460	380	460

ID	Term
C000590451	abemaciclib
C089740	abiraterone
D011241	Prednisone
D011239	Prednisolone