Study: NCT03896789

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia, severe
Frequency: 1 affected / 55 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Notes: Shock, severe
Frequency: 4 affected / 55 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, severe
Frequency: 2 affected / 55 at risk

Adverse event: Other: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other severe complications free text, classified by investigators as associated with Respiratory System
Frequency: 2 affected / 55 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Pneumonia, mild or moderate
Frequency: 6 affected / 55 at risk

Adverse event: Shock
Serious: no
Organ System: General disorders
Notes: Shock, mild or moderate
Frequency: 2 affected / 55 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: no
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, mild or moderate
Frequency: 2 affected / 55 at risk

Adverse event: Other: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Other mild or moderate complications free text, classified by investigators as associated with Infections
Frequency: 4 affected / 55 at risk

Adverse event: Other: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Respiratory System
Frequency: 5 affected / 55 at risk

Adverse event: Other: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Neurologic/Nervous System
Frequency: 5 affected / 55 at risk

Adverse event: Other: Cardiac
Serious: no
Organ System: Cardiac disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Cardiology
Frequency: 1 affected / 55 at risk

Adverse event: Other: Electrolyte/Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Electrolytes/Metabolic
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia, severe
Frequency: 9 affected / 208 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia, severe
Frequency: 2 affected / 208 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Notes: Shock, severe
Frequency: 17 affected / 208 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, severe
Frequency: 3 affected / 208 at risk

Adverse event: Other: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other severe complications free text, classified by investigators as associated with Respiratory System
Frequency: 3 affected / 208 at risk

Adverse event: Other: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Other severe complications free text, classified by investigators as associated with Neurologic/Nervous System
Frequency: 12 affected / 208 at risk

Adverse event: Other: Electrolyte/Metabolic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 208 at risk

Adverse event: Other: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 208 at risk

Adverse event: Other: Infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 208 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Pneumonia, mild or moderate
Frequency: 49 affected / 208 at risk

Adverse event: Shock
Serious: no
Organ System: General disorders
Notes: Shock, mild or moderate
Frequency: 3 affected / 208 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: no
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, mild or moderate
Frequency: 2 affected / 208 at risk

Adverse event: Other: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Other mild or moderate complications free text, classified by investigators as associated with Infections
Frequency: 4 affected / 208 at risk

Adverse event: Other: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Respiratory System
Frequency: 4 affected / 208 at risk

Adverse event: Other: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Neurologic/Nervous System
Frequency: 20 affected / 208 at risk

Adverse event: Other: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Gastrointestinal System
Frequency: 1 affected / 208 at risk

Adverse event: Other: Hematology
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Hematology
Frequency: 2 affected / 208 at risk

Adverse event: Other: Electrolyte/Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Electrolytes/Metabolic
Frequency: 2 affected / 208 at risk

Adverse event: Other: Ophthalmalogical
Serious: no
Organ System: Eye disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Ophthalmology
Frequency: 2 affected / 208 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia, severe
Frequency: 1 affected / 61 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Notes: Shock, severe
Frequency: 3 affected / 61 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, severe
Frequency: 1 affected / 61 at risk

Adverse event: Other: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other severe complications free text, classified by investigators as associated with Respiratory System
Frequency: 2 affected / 61 at risk

Adverse event: Other: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Other severe complications free text, classified by investigators as associated with Neurologic/Nervous System
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Pneumonia, mild or moderate
Frequency: 10 affected / 61 at risk

Adverse event: Shock
Serious: no
Organ System: General disorders
Notes: Shock, mild or moderate
Frequency: 1 affected / 61 at risk

Adverse event: Peritonitis
Serious: no
Organ System: Infections and infestations
Notes: Peritonitis, mild or moderate
Frequency: 1 affected / 61 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: no
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, mild or moderate
Frequency: 1 affected / 61 at risk

Adverse event: Other: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Other mild or moderate complications free text, classified by investigators as associated with Infections
Frequency: 4 affected / 61 at risk

Adverse event: Other: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Neurologic/Nervous System
Frequency: 2 affected / 61 at risk

Adverse event: Other: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Gastrointestinal System
Frequency: 1 affected / 61 at risk

Adverse event: Other: Hematology
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Hematology
Frequency: 1 affected / 61 at risk

Adverse event: Other: Electrolyte/Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Electrolytes/Metabolic
Frequency: 1 affected / 61 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia, severe
Frequency: 5 affected / 181 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia, severe
Frequency: 1 affected / 181 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Notes: Shock, severe
Frequency: 8 affected / 181 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, severe
Frequency: 2 affected / 181 at risk

Adverse event: Other: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: Other severe complications free text, classified by investigators as associated with Neurologic/Nervous System
Frequency: 4 affected / 181 at risk

Adverse event: Other: Electrolyte/Metabolic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 181 at risk

Adverse event: Other: Infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 181 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Pneumonia, mild or moderate
Frequency: 40 affected / 181 at risk

Adverse event: Shock
Serious: no
Organ System: General disorders
Notes: Shock, mild or moderate
Frequency: 2 affected / 181 at risk

Adverse event: Peritonitis
Serious: no
Organ System: Infections and infestations
Notes: Peritonitis, mild or moderate
Frequency: 1 affected / 181 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: no
Organ System: Nervous system disorders
Notes: Intraparenchymal hemorrhage, mild or moderate
Frequency: 1 affected / 181 at risk

Adverse event: Other: Infectious
Serious: no
Organ System: Infections and infestations
Notes: Other mild or moderate complications free text, classified by investigators as associated with Infections
Frequency: 19 affected / 181 at risk

Adverse event: Other: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Respiratory System
Frequency: 3 affected / 181 at risk

Adverse event: Other: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Neurologic/Nervous System
Frequency: 21 affected / 181 at risk

Adverse event: Other: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Gastrointestinal System
Frequency: 2 affected / 181 at risk

Adverse event: Other: Hematology
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Hematology
Frequency: 3 affected / 181 at risk

Adverse event: Other: Electrolyte/Metabolic
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Electrolytes/Metabolic
Frequency: 2 affected / 181 at risk

Adverse event: Other: Ophthalmalogical
Serious: no
Organ System: Eye disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Ophthalmology
Frequency: 1 affected / 181 at risk

Adverse event: Other: Kidney
Serious: no
Organ System: Renal and urinary disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Kidney/Nephrology
Frequency: 1 affected / 181 at risk

Adverse event: Other: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Other mild or moderate complications free text, classified by investigators as associated with Dermatology
Frequency: 1 affected / 181 at risk