Study: NCT05359666

Adverse event: Blood/Lymphatic SAEs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 294 at risk

Adverse event: Cardiac SAEs
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 294 at risk

Adverse event: GI SAEs
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 294 at risk

Adverse event: General SAEs
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 294 at risk

Adverse event: Hepatobiliary SAEs
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Infection SAEs
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 294 at risk

Adverse event: Injury SAEs
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 294 at risk

Adverse event: Nervous System SAEs
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 294 at risk

Adverse event: Renal/Urinary SAEs
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 294 at risk

Adverse event: Respiratory SAEs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 294 at risk

Adverse event: Vascular SAEs
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 294 at risk

Adverse event: Blood/Lymphatic AEs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 58 affected / 294 at risk

Adverse event: Cardiac AEs
Serious: no
Organ System: Cardiac disorders
Frequency: 48 affected / 294 at risk

Adverse event: Ear/Labyrinth AEs
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 294 at risk

Adverse event: Endocrine AEs
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 294 at risk

Adverse event: Ocular AEs
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 294 at risk

Adverse event: GI AEs
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 70 affected / 294 at risk

Adverse event: General AEs
Serious: no
Organ System: General disorders
Frequency: 39 affected / 294 at risk

Adverse event: Hepatobiliary AEs
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Infection AEs
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 294 at risk

Adverse event: Injury AEs
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 51 affected / 294 at risk

Adverse event: Investigational AEs
Serious: no
Organ System: Investigations
Frequency: 5 affected / 294 at risk

Adverse event: Metabolic AEs
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 294 at risk

Adverse event: Musculoskeletal AEs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 294 at risk

Adverse event: Neoplasm AEs
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Nervous System AEs
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 294 at risk

Adverse event: Psychiatric AEs
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 294 at risk

Adverse event: Renal/Urinary AEs
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 294 at risk

Adverse event: Reproductive System AEs
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 294 at risk

Adverse event: Respiratory AEs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 294 at risk

Adverse event: Skin/Subcutaneous Tissue AEs
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 294 at risk

Adverse event: Vascular AEs
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 294 at risk

Adverse event: Adverse Device Effects
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Blood/Lymphatic SAEs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 298 at risk

Adverse event: Cardiac SAEs
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 298 at risk

Adverse event: GI SAEs
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 298 at risk

Adverse event: General SAEs
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 298 at risk

Adverse event: Hepatobiliary SAEs
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 298 at risk

Adverse event: Infection SAEs
Serious: yes
Organ System: Infections and infestations
Frequency: 29 affected / 298 at risk

Adverse event: Injury SAEs
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 298 at risk

Adverse event: Metabolic SAEs
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 298 at risk

Adverse event: Nervous System SAEs
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 298 at risk

Adverse event: Psychiatric SAEs
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 298 at risk

Adverse event: Renal/Urinary SAEs
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 298 at risk

Adverse event: Respiratory SAEs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 298 at risk

Adverse event: Vascular SAEs
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 298 at risk

Adverse event: Blood/Lymphatic AEs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 60 affected / 298 at risk

Adverse event: Cardiac AEs
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 298 at risk

Adverse event: GI AEs
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 298 at risk

Adverse event: General AEs
Serious: no
Organ System: General disorders
Frequency: 36 affected / 298 at risk

Adverse event: Hepatobiliary AEs
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 298 at risk

Adverse event: Infection AEs
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 298 at risk

Adverse event: Injury AEs
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 48 affected / 298 at risk

Adverse event: Investigational AEs
Serious: no
Organ System: Investigations
Frequency: 12 affected / 298 at risk

Adverse event: Metabolic AEs
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 298 at risk

Adverse event: Musculoskeletal AEs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 298 at risk

Adverse event: Neoplasm AEs
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 298 at risk

Adverse event: Nervous System AEs
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 298 at risk

Adverse event: Psychiatric AEs
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 298 at risk

Adverse event: Renal/Urinary AEs
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 298 at risk

Adverse event: Reproductive System AEs
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 298 at risk

Adverse event: Respiratory AEs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 55 affected / 298 at risk

Adverse event: Skin/Subcutaneous Tissue AEs
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 298 at risk

Adverse event: Vascular AEs
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 298 at risk