Trial Outcomes & Findings for A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC) (NCT NCT02384382)

Last Updated: 2020-05-05

Results Overview

Bone lesion responded: if its change from baseline in SUVtotal is below limit of agreement (LOA, no specific value, based upon test/retest analysis using software). SUVtotal: total NaF uptake,indicated tumor burden across all bone lesions/in individual lesions reflecting bone-metastatic prostate cancer.NaF-3 performed on any of these: 1) prostate-specific antigen (PSA) progression(increase of \>=25% and absolute increase of \>=2.0 ng/mL above nadir); 2) bone progressive disease(PD)(appearance of \>=2 new lesions after screening assessed by technetium Tc 99m medronate \[99mTc-MDP\] bone scintigraphy); 3) soft tissue PD; 4) clinically relevant progression by investigator; 5) at 2 years without progression after treatment initiation. PD, RECIST1.1:\>=20% increase in sum of diameters of target lesions,(reference smallest sum on study, included baseline sum if that is smallest on study),relative increase of 20%,sum of diameters indicated absolute increase of \>=5mm, appearance of \>=1 new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

At NaF-3 schedule: at time of PSA, or radiographic(bone or soft tissue), or clinically relevant progression, or at 2years without progression after treatment initiation, whichever occurred first(From first dose of study drug up to maximum of 34.1 months)

Results posted on

2020-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Enzalutamide 160 Milligram (mg) (18F-NaF PET/CT) Chemotherapy naive participants with progressive bone-metastatic castration-resistant prostate cancer (CRPC) were enrolled to receive enzalutamide 160 milligram (mg) per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-sodium fluoride positron-emission tomography/computed tomography bone imaging (18F-NaF PET/CT) was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
Overall Study STARTED	23
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Enzalutamide 160 Milligram (mg) (18F-NaF PET/CT) Chemotherapy naive participants with progressive bone-metastatic castration-resistant prostate cancer (CRPC) were enrolled to receive enzalutamide 160 milligram (mg) per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-sodium fluoride positron-emission tomography/computed tomography bone imaging (18F-NaF PET/CT) was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
Overall Study Transitioned to study-NCT02960022	5
Overall Study Death	1
Overall Study Adverse Event	1
Overall Study Disease progression	16

Baseline Characteristics

A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enzalutamide 160 mg (18F-NaF PET/CT) n=23 Participants Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
Age, Continuous	72.0 years STANDARD_DEVIATION 10.07 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: At NaF-3 schedule: at time of PSA, or radiographic(bone or soft tissue), or clinically relevant progression, or at 2years without progression after treatment initiation, whichever occurred first(From first dose of study drug up to maximum of 34.1 months)

Population: Analysis population included all enrolled participants who received any amount of study medication and who also have non-missing scans at both NaF-1 and NaF-3. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Enzalutamide 160 mg (18F-NaF PET/CT) n=22 Participants Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
Percentage of Participants With at Least (>=) 1 Responding Bone Lesion Assessed by Total Sodium Fluoride (NaF) Standardized Uptake Value [SUVtotal] at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule	100.0 percentage of participants Interval 84.6 to 100.0

SECONDARY outcome

Global SUVhetero score:Sum of(SUVmean of each lesion minus global SUVmean of all lesion)\^2/number of lesions,measure of heterogeneity of tumor activity across all bone lesions.SUVmean(mean NaF uptake)indicated average activity of each lesions.Real limits for SUVhetero score ranged:0(minimum) to infinite(maximum).Higher global SUVhetero score:more heterogeneity in bone lesion activity.NaF-3 performed on any of these 1)PSA progression(increase of\>=25% and absolute increase of\>=2.0ng/mL above nadir);2)bone PD(appearance of\>=2 new lesions after screening assessed by 99mTc-MDP bone scintigraphy);3)soft tissue PD(RECIST1.1);4)clinically relevant progression by investigator;5)at 2years without progression after treatment initiation.PD perRECIST1.1:\>=20%increase in sum of diameters of target lesions,(reference smallest sum on study,this included baseline sum if that is smallest on study),relative increase of20%,sum of diameters indicated absolute increase of\>=5mm,appearance of\>=1 new lesions.

Outcome measures

Outcome measures
Measure	Enzalutamide 160 mg (18F-NaF PET/CT) n=22 Participants Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
Mean Heterogeneity of Response Across All Bone Lesions as Measured by Global Heterogeneity of NaF Standardized Uptake (SUVhetero) Score at Third 18F-NaF PET/CT Imaging (NaF-3) Schedule	3.9 unit on SUVhetero score Standard Deviation 3.17

Adverse Events

Enzalutamide 160 mg

Serious events: 9 serious events

Other events: 22 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Enzalutamide 160 mg n=23 participants at risk Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
Cardiac disorders Mitral valve incompetence	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Asthenia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Diarrhoea	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Cellulitis	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Psychiatric disorders Completed suicide	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Haematuria	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Urinary retention	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Urinary tract obstruction	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Vascular disorders Deep vein thrombosis	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Vascular disorders Hypotension	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.

Other adverse events

Other adverse events
Measure	Enzalutamide 160 mg n=23 participants at risk Chemotherapy naive participants with progressive bone-metastatic CRPC were enrolled to receive enzalutamide 160 mg per day as 4 capsules (each capsule of 40 mg), orally, once daily. 18F-NaF PET/CT was evaluated to determine treatment response in metastatic bone lesions of enrolled participants in the study. Maximum treatment exposure was 34.1 months.
Blood and lymphatic system disorders Anaemia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Blood and lymphatic system disorders Microcytic anaemia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Cardiac disorders Atrial tachycardia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Cardiac disorders Ventricular tachycardia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Eye disorders Cataract	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Eye disorders Retinal haemorrhage	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Asthenia	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Chest pain	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Fatigue	82.6% 19/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Gait disturbance	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Inflammation	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Influenza like illness	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Malaise	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Oedema peripheral	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Pain	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
General disorders Pyrexia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Abdominal discomfort	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Abdominal pain	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Constipation	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Diarrhoea	21.7% 5/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Dyspepsia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Dysphagia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Nausea	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Oesophagitis	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Toothache	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Umbilical hernia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Gastrointestinal disorders Vomiting	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Diverticulitis	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Fungal skin infection	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Gastroenteritis Escherichia coli	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Infected skin ulcer	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Nasopharyngitis	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Post procedural infection	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Sepsis	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Sinusitis	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Upper respiratory tract infection	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Infections and infestations Urinary tract infection	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Injury, poisoning and procedural complications Arthropod bite	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Injury, poisoning and procedural complications Chest injury	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Injury, poisoning and procedural complications Fall	26.1% 6/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Injury, poisoning and procedural complications Procedural pain	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Injury, poisoning and procedural complications Rib fracture	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Injury, poisoning and procedural complications Spinal compression fracture	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Injury, poisoning and procedural complications Sternal fracture	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Investigations Blood creatinine increased	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Investigations Weight decreased	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Metabolism and nutrition disorders Decreased appetite	17.4% 4/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Metabolism and nutrition disorders Hyperglycaemia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Metabolism and nutrition disorders Hyperkalaemia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Metabolism and nutrition disorders Hypocalcaemia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Metabolism and nutrition disorders Hypophosphataemia	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	26.1% 6/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Arthritis	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Back pain	26.1% 6/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Bone pain	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Flank pain	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Groin pain	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Joint swelling	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	17.4% 4/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Myalgia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Neck pain	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Ageusia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Balance disorder	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Dizziness	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Dysgeusia	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Headache	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Hypoaesthesia	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Memory impairment	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Neuropathy peripheral	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Paraesthesia	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Parosmia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Peripheral sensory neuropathy	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders Sciatica	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Nervous system disorders VIIth nerve paralysis	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Psychiatric disorders Anxiety	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Psychiatric disorders Insomnia	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Acute kidney injury	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Bladder pain	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Cystitis noninfective	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Haematuria	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Stress urinary incontinence	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Urinary incontinence	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Urinary tract obstruction	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Renal and urinary disorders Urinary tract pain	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Reproductive system and breast disorders Pelvic pain	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Cough	13.0% 3/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Dysphonia	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Respiratory, thoracic and mediastinal disorders Sinus congestion	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Skin and subcutaneous tissue disorders Dry skin	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Skin and subcutaneous tissue disorders Rash	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Skin and subcutaneous tissue disorders Skin burning sensation	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Skin and subcutaneous tissue disorders Swelling face	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Surgical and medical procedures Cyst drainage	4.3% 1/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Vascular disorders Hot flush	17.4% 4/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Vascular disorders Hypertension	17.4% 4/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.
Vascular disorders Hypotension	8.7% 2/23 • From first dose of study drug up to 30 days after the last dose of study treatment or initiation of cytotoxic chemotherapy, (lutamide- bicalutamide, nilutamide,or flutamide), or initiation of new investigational therapy, whichever occurred first (up to 35.1 months) Same event may appear as adverse events (AEs) and serious adverse events (SAEs), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non serious event during study. As treated population included all enrolled participants who received any amount of study medication.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER