TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02753413

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 20 affected / 49 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 49 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 51 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 46 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 51 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 51 at risk
Study: NCT02753816

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Notes: Suffered PE (Pulmonary Embolism) 3 days following treatment

* PE was determined to be "Severe, Unlikely Related"
Frequency: 1 affected / 14 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Patient suffered an Acute Myocardial Infarction one day after study procedure
Frequency: 1 affected / 14 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: suffered MI (Myocardial Infarction) one day following treatment

- MI was determined to be "Severe, Not at all related"
Frequency: 1 affected / 17 at risk
Study: NCT02753842

Adverse event: Symptomatic STI or recent STI diagnosis
Serious: no
Organ System: Investigations
Frequency: 3 affected / 468 at risk

Adverse event: Condom- or lube-related discomfort
Serious: no
Organ System: Investigations
Frequency: 4 affected / 468 at risk

Adverse event: Partner discomfort with lubricant
Serious: no
Organ System: Investigations
Frequency: 1 affected / 468 at risk

Adverse event: Partner Urinary Tract Infection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 468 at risk

Adverse event: Symptomatic STI or recent STI diagnosis
Serious: no
Organ System: Investigations
Frequency: 4 affected / 469 at risk

Adverse event: Condom- or lube-related discomfort
Serious: no
Organ System: Investigations
Frequency: 7 affected / 469 at risk

Adverse event: Symptomatic STI or recent STI diagnosis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 464 at risk

Adverse event: Condom- or lube-related discomfort
Serious: no
Organ System: Investigations
Frequency: 4 affected / 464 at risk
Study: NCT02754440

Adverse event: Citrate toxicity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 99 at risk

Adverse event: Citrate toxicity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 101 at risk

Adverse event: Citrate toxicity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 100 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 35 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk
Study: NCT02754479

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Discomfort
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Post inflammatory pigmentation change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3 at risk

Adverse event: Darkening of Vessel
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Crusting
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nodule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT02754492

Adverse event: Citrate toxicity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 95 at risk

Adverse event: Injection site extravasation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 23 at risk
Study: NCT02754518

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension
Frequency: 4 affected / 40 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 40 at risk
Study: NCT02754661

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Post procedural haemorrahage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Anorectal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 145 at risk

Adverse event: Haemmorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 145 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 145 at risk

Adverse event: Rectal Haemorrage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 141 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 141 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 141 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 141 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 141 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 141 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 141 at risk
Study: NCT02755116

Adverse event: Dizziness or lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 71 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 71 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 71 at risk

Adverse event: Dizziness or lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 69 at risk
Study: NCT02755467

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 22 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 22 at risk
Study: NCT02755545

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 62 at risk
Study: NCT02755935

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: death from recurrence of a previous medical condition unrelated to the device or procedure
Frequency: 1 affected / 24 at risk

Adverse event: skin flap
Serious: yes
Organ System: Infections and infestations
Notes: Incision breakdown, revised successfully in the OR
Frequency: 1 affected / 24 at risk

Adverse event: Facial nerve
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Facial nerve weakness following surgery, Treated with oral medications and resolved.
Frequency: 1 affected / 24 at risk

Adverse event: Vertigo or dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: with stimulation of specific electrodes
Frequency: 1 affected / 24 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Ear and labyrinth disorders
Notes: tingling/shocking with stimulation of specific electrodes. Programmed around, resolved
Frequency: 1 affected / 24 at risk

Adverse event: Device related/programming problems
Serious: no
Organ System: Product Issues
Notes: open circuit
Frequency: 3 affected / 24 at risk
Study: NCT02756013

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk
Study: NCT02756182

Adverse event: High blood pressure with autonomic dysreflexia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: One patient presented an episode of high blood pressure with autonomic dysreflexia, and the infusion pump was therefore stopped at 335 ml before maximum capacity was reached. Adverse event was not related to the device used (catheter).
Frequency: 1 affected / 25 at risk
Study: NCT02756338

Adverse event: Infection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 77 at risk

Adverse event: Surrounding Tissue Damage
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 77 at risk
Study: NCT02756403

Adverse event: Inpatient Hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 41 at risk
Study: NCT02756624

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 343 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 343 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 343 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 343 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 343 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 343 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 343 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 343 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 343 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 173 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 173 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 173 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 173 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 173 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 173 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 173 at risk
Study: NCT02756689

Adverse event: Endometritis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Diagnosed with endometritis from admission until 30 days after discharge
Frequency: 1 affected / 64 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 64 at risk

Adverse event: Umbilical cord arterial pH less than 7.1
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 64 at risk

Adverse event: Umbilical cord arterial base deficit greater than 12
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 64 at risk

Adverse event: Birth injuries
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Birth injuries defined as cephalohematoma, subgaleal hematoma, brachial plexus injury, clavicle or humerus fracture, and scalp laceration.
Frequency: 2 affected / 64 at risk

Adverse event: Admission to the NICU
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 64 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Diagnosed with endometritis from admission until 30 days after discharge
Frequency: 1 affected / 65 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 65 at risk

Adverse event: Readmission within 30 days of discharge
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 65 at risk

Adverse event: Umbilical cord arterial pH less than 7.1
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 65 at risk

Adverse event: Birth injuries
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Birth injuries defined as cephalohematoma, subgaleal hematoma, brachial plexus injury, clavicle or humerus fracture, and scalp laceration.
Frequency: 1 affected / 65 at risk

Adverse event: Admission to the NICU
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 65 at risk
Study: NCT02756806

Adverse event: Frosting
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 7 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 7 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 7 at risk
Study: NCT02756819

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1934 at risk

Adverse event: Deafness neurosensory
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1934 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 1934 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1934 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1934 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1934 at risk

Adverse event: Left ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1934 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1934 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1934 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1934 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1934 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1934 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Therapeutic product effect increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1934 at risk

Adverse event: Drug ineffective
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1934 at risk
Study: NCT02757092

Adverse event: Prolonged air leak (PAL)
Serious: no
Organ System: Surgical and medical procedures
Notes: Prolonged air leak (PAL) is one of the most common postoperative complications after pulmonary resection Pleural adhesion was associated with increased risk of PAL ,and will prolong hospital stay after surgery.
Frequency: 6 affected / 18 at risk

Adverse event: Prolonged air leak (PAL)
Serious: no
Organ System: Surgical and medical procedures
Notes: Prolonged air leak (PAL) is one of the most common postoperative complications after pulmonary resection Pleural adhesion was associated with increased risk of PAL ,and will prolong hospital stay after surgery.
Frequency: 6 affected / 18 at risk
Study: NCT02757430

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk

Adverse event: Recurrence of Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk

Adverse event: Recurrent Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk

Adverse event: Esophageal Lesion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 503 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 503 at risk

Adverse event: Tachy-Brady Syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 503 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 503 at risk
Study: NCT02757521

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Worsened Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1 at risk

Adverse event: Feeling more cold mostly in feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk
Study: NCT02757872

Adverse event: Microalbuminuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 545 at risk

Adverse event: Microalbuminuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 570 at risk

Adverse event: Microalbuminuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 576 at risk

Adverse event: Microalbuminuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 541 at risk
Study: NCT02757885

Adverse event: Non-engraftment
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Graft failure happens when the new cells don't make the new white blood cells, red blood cells, and platelets you need. This is also called "failure to engraft" or "non-engraftment.
Frequency: 1 affected / 6 at risk

Adverse event: Neurotoxicity
Serious: yes
Organ System: Nervous system disorders
Notes: Posterior reversible encephalopathy syndrome
Frequency: 2 affected / 6 at risk

Adverse event: Graft-versus-host disease (GVHD)
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 6 at risk

Adverse event: Thrombotic microangiopathy (TMA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Epstein-Barr virus (EBV)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 6 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cytomegalovirus infection (CMV)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: BK virus (BKV)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 6 at risk

Adverse event: Bacteriemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 6 at risk
Study: NCT02757963

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 1658 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1658 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1658 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1658 at risk
Study: NCT02758132

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: subject was admitted to the hospital on 9/3/2016. Subject had a significant history of CVA (stroke) with atrial fibrillation. Patient elected hospice and care expired on 9/8/2016. The event was a grade 5 and deemed unrelated to study treatment.
Frequency: 1 affected / 1 at risk