Study: NCT03538938

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 83 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Kidney disease, or kidney or bladder infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pregnancy, delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 84 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 84 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 84 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 80 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 80 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 80 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 80 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 80 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 85 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 85 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Chronic obstructive pulmonary disease or need for supplemental oxygen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 85 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 85 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 82 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 82 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 82 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 82 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 84 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Anemia or bleeding disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 84 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 84 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Cancer, biopsy, polyp, or cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 82 at risk

Adverse event: Kidney disease, or kidney or bladder infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Chronic obstructive pulmonary disease or need for supplemental oxygen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Diabetes complications, thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cancer, biopsy, polyp, or cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 80 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 80 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 80 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: Diabetes complications, thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 81 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 81 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Reaction to new psychiatric medication
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 81 at risk

Adverse event: Chronic obstructive pulmonary disease or need for supplemental oxygen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 81 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 81 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 81 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 81 at risk

Adverse event: Cancer, biopsy, polyp, or cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 81 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 81 at risk

Adverse event: Kidney disease, or kidney or bladder infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 81 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 81 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 80 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 80 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 80 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 82 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Anemia or bleeding disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 85 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 85 at risk

Adverse event: Chronic obstructive pulmonary disease or need for supplemental oxygen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 85 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 85 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Anemia or bleeding disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cancer, biopsy, polyp, or cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 82 at risk

Adverse event: Suicidal ideation, bipolar, schizophrenia, anxiety, or alcohol use disorder symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 82 at risk

Adverse event: Chronic obstructive pulmonary disease or need for supplemental oxygen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Infection prompting hospitalization
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Cardiovascular diagnoses and events
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 83 at risk

Adverse event: Diabetes complications, thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 83 at risk

Adverse event: Gastrointestinal disease, pancreatitis, ulcer, or injury (e.g., hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Injury or poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Cancer, biopsy, polyp, or cyst
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 83 at risk

Adverse event: Stroke, seizure, aneurysm, or suspected multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Reaction to new psychiatric medication
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 83 at risk

Adverse event: Chronic obstructive pulmonary disease or need for supplemental oxygen
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 83 at risk

Adverse event: Planned orthopedic, gastric, or hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 83 at risk

Adverse event: Unknown or other reason for hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk