Study: NCT02719327

Adverse event: Chest pain or tightness
Serious: yes
Organ System: Cardiac disorders
Notes: Participant was admitted to hospital after presenting chest tightness
Frequency: 1 affected / 63 at risk

Adverse event: Laparoscopic prostatectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Participant had planned surgery for prostate cancer.
Frequency: 1 affected / 63 at risk

Adverse event: Surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Participant underwent bypass surgery
Frequency: 1 affected / 63 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Cardiac disorders
Notes: Participant admitted to hospital after an aortic aneurysm
Frequency: 1 affected / 63 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant hospitalized after developing spontaneous pneumothorax.
Frequency: 1 affected / 63 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant presented to the hospital after a fall.
Frequency: 2 affected / 63 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Participant was admitted to hospital after developing a UTI.
Frequency: 1 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Participant reported headache following an LP
Frequency: 1 affected / 63 at risk

Adverse event: Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Participant suffered an accidental injury, resolved.
Frequency: 1 affected / 63 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 63 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Participant reported sweating and itching after starting study drug.
Frequency: 1 affected / 63 at risk

Adverse event: Distended bladder
Serious: no
Organ System: Renal and urinary disorders
Notes: Resolved.
Frequency: 1 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Cellulitus, eye
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: COVID19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Prostate cancer
Frequency: 1 affected / 63 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Participant experienced breathing issues related to sinus infection.
Frequency: 1 affected / 63 at risk

Adverse event: Mortatilty
Serious: yes
Organ System: General disorders
Notes: Participant passed away after falling down a staircase.
Frequency: 1 affected / 68 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was hospitalized after COPD attack
Frequency: 1 affected / 68 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Participant admitted after presenting to hospital with heart palpitations.
Frequency: 1 affected / 68 at risk

Adverse event: non-ST elevated myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Participant hospitalized after a NSTEMI.
Frequency: 1 affected / 68 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: General disorders
Notes: Participant hospitalized after presenting with neck pain and inability to swallow.
Frequency: 1 affected / 68 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Participant hospitalized after presenting with high blood pressure.
Frequency: 1 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Participant reported headache following an LP
Frequency: 2 affected / 68 at risk

Adverse event: Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Participant suffered an accidental injury, resolved.
Frequency: 2 affected / 68 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 68 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Participant had a synovial cyst removed from spine (L4/L5).
Frequency: 1 affected / 68 at risk

Adverse event: Abscess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Resolved.
Frequency: 2 affected / 68 at risk

Adverse event: Haematoma
Serious: no
Organ System: Renal and urinary disorders
Notes: Hematoma following orchiectomy was resolved.
Frequency: 1 affected / 68 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 68 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Participant fell after feeling light-headed.
Frequency: 1 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Prostate cancer
Frequency: 2 affected / 68 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Gastrointestinal disorders
Notes: Positive Colorectal screening
Frequency: 1 affected / 68 at risk

Adverse event: orthopedic
Serious: no
Organ System: Surgical and medical procedures
Notes: wrist pain following surgery
Frequency: 1 affected / 68 at risk