Study: NCT04407507

Adverse event: HT Central nervous system and spinal cord infections
Serious: yes
Organ System: Nervous system disorders
Notes: encephalitis
Frequency: 1 affected / 33 at risk

Adverse event: HLT RASH
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: HLT Urinary tract infections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 33 at risk

Adverse event: HLGT Epidermal and dermal diseases
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Maculo-papular pruritus
Frequency: 1 affected / 33 at risk

Adverse event: PF Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: HLGT anxiety disorders and symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 1 affected / 33 at risk

Adverse event: HLGT Inflammatory gastrointestinal diseases
Serious: no
Organ System: Gastrointestinal disorders
Notes: gastritis
Frequency: 1 affected / 33 at risk

Adverse event: LLT Otitis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: HLT Nasal congestion and inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nasal congestion
Frequency: 1 affected / 33 at risk

Adverse event: LLT Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: HLT RASH
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: HLT Nasal congestion and inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nasal congestion
Frequency: 1 affected / 33 at risk

Adverse event: LLT Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: HLGT Glucose metabolism disorders (including diabetes mellitus)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperglycemia
Frequency: 1 affected / 33 at risk

Adverse event: SOC Blood and lymphatic system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukocytosis
Frequency: 1 affected / 33 at risk

Adverse event: HLT Musculoskeletal pain and discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: low back pain
Frequency: 2 affected / 33 at risk

Adverse event: LLT acidity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT elevated Lipase
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: NAUSEA
Frequency: 2 affected / 33 at risk

Adverse event: SOC Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 1 affected / 33 at risk

Adverse event: PT Acid Peptic Disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT Tachycardia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: LLT Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk