Study: NCT03861767

Adverse event: From time of prescription until 90 days after surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Immune system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 4 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 7 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Vascular disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 39 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 7 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 4 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Vascular disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 4 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 4 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Investigations
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Psychiatric disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Renal and urinary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 20 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 5 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 5 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 5 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 5 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 5 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Renal and urinary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 5 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 3 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 3 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 4 affected / 39 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 4 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 3 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 39 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 39 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 39 at risk

Adverse event: From time of prescription until 90 days after surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 5 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Vascular disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 5 affected / 19 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 19 at risk

Adverse event: From time of prescription until 90 days after surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 8 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 8 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 8 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 8 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 8 at risk

Adverse event: From time of prescription until 90 days after surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 3 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 6 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Renal and urinary disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 6 affected / 40 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 3 affected / 40 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 40 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 40 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 40 at risk

Adverse event: From time of prescription until 90 days after surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 26 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 3 affected / 26 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 3 affected / 26 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 6 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: yes
Organ System: Vascular disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 106 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 6 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Infections and infestations
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 106 at risk

Adverse event: Time of prescription until 90 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 2 affected / 106 at risk

Adverse event: Time of prescription of study drug until 90 days after surgery
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 1 affected / 106 at risk