Study: NCT03656744

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE of MI occurred on Study Day 112 and resolved same day. Presented to emergency with complaint of sharp substernal chest pain. Had severe distal RCA/r PDA disease. Successful per cutaneous intervention performed. Study drug discont. Unrelated.
Frequency: 1 affected / 33 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection, Nasopharyngitis, bronchitis, gastroenteritis viral,
Frequency: 4 affected / 33 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain upper, abdominal pain, constipation, flatulence, gastroesophageal reflux disease,
Frequency: 14 affected / 33 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 3 affected / 33 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, investigations (alanine aminotransferase increased, blood glucose decreased)
Frequency: 2 affected / 33 at risk

Adverse event: Respiratory disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, nasal congestion, sinus congestion
Frequency: 1 affected / 33 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, alopecia
Frequency: 1 affected / 33 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Corneal abrasion, heat exhaustion, joint injury
Frequency: 1 affected / 33 at risk

Adverse event: Decreased oxygen saturation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject was admitted to hospital for elective surgery (left shoulder arthroscopic surgery). Postoperatively, subject developed hypoxia and was placed on oxygen. Hospitalization was prolonged.
Frequency: 1 affected / 34 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE of MI occurred on Study Day 112 and resolved same day. Presented to emergency with complaint of sharp substernal chest pain. Had severe distal RCA/r PDA disease. Successful per cutaneous intervention performed. Study drug discont. Unrelated.
Frequency: 1 affected / 34 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection, Nasopharyngitis, bronchitis, gastroenteritis viral,
Frequency: 5 affected / 34 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain upper, abdominal pain, constipation, flatulence, gastroesophageal reflux disease,
Frequency: 19 affected / 34 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 5 affected / 34 at risk

Adverse event: General Disorders
Serious: no
Organ System: General disorders
Notes: Fatigue, investigations (alanine aminotransferase increased, blood glucose decreased)
Frequency: 3 affected / 34 at risk

Adverse event: Respiratory disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, nasal congestion, sinus congestion
Frequency: 1 affected / 34 at risk

Adverse event: Metabolic disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite, dehydration, diabetes mellitus inadequate control, hypertriglyceridemia
Frequency: 2 affected / 34 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, alopecia
Frequency: 2 affected / 34 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hypothyroidism,
Frequency: 2 affected / 34 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Bladder transitional cell carcinoma requiring hospitalization. after presenting to hospital on Study Day 116 with hematuria. Resolved Study Day 117. Unrelated.
Frequency: 1 affected / 33 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection, Nasopharyngitis, bronchitis, gastroenteritis viral,
Frequency: 11 affected / 33 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, nausea, abdominal pain upper, abdominal pain, constipation, flatulence, gastroesophageal reflux disease,
Frequency: 10 affected / 33 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 3 affected / 33 at risk

Adverse event: Respiratory disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, nasal congestion, sinus congestion
Frequency: 3 affected / 33 at risk

Adverse event: Metabolic disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite, dehydration, diabetes mellitus inadequate control, hypertriglyceridemia
Frequency: 2 affected / 33 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, alopecia
Frequency: 1 affected / 33 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Corneal abrasion, heat exhaustion, joint injury
Frequency: 2 affected / 33 at risk