Study: NCT04308668

Adverse event: COVID-related hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: n=5 vs. n=8 hospitalizations in early treatment population, n=1 vs. n=1 hospitalizations in postexposure prophylaxis population
Frequency: 6 affected / 658 at risk

Adverse event: Nausea or upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 146 affected / 658 at risk

Adverse event: Diarrhea, abdominal pain, vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 131 affected / 658 at risk

Adverse event: Irritability, dizziness, vertigo
Serious: no
Organ System: General disorders
Frequency: 39 affected / 658 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 658 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 658 at risk

Adverse event: Visual changes
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 658 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 658 at risk

Adverse event: Taste change or dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 658 at risk

Adverse event: Allergic reaction (non-anaphylaxis)
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 658 at risk

Adverse event: Hot flashes, night sweats, palpitations
Serious: no
Organ System: General disorders
Frequency: 2 affected / 658 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 658 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 658 at risk

Adverse event: COVID-related hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: n=5 vs. n=8 hospitalizations in early treatment population, n=1 vs. n=1 hospitalizations in postexposure prophylaxis population
Frequency: 9 affected / 654 at risk

Adverse event: Hospitalizations not related to COVID or study medicine
Serious: yes
Organ System: Cardiac disorders
Notes: Adjudication was conducted by blinded investigators.
Frequency: 2 affected / 654 at risk

Adverse event: Nausea or upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 654 at risk

Adverse event: Diarrhea, abdominal pain, vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 654 at risk

Adverse event: Irritability, dizziness, vertigo
Serious: no
Organ System: General disorders
Frequency: 26 affected / 654 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 654 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 654 at risk

Adverse event: Visual changes
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 654 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 654 at risk

Adverse event: Taste change or dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 654 at risk

Adverse event: Allergic reaction (non-anaphylaxis)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 654 at risk

Adverse event: Hot flashes, night sweats, palpitations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 654 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 654 at risk

Adverse event: Panic
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 654 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 654 at risk