Study: NCT04021121

Adverse event: Stevens-Johnson Syndrome R/O Exfoliative Dermatitis Induced by Initiation of Zidovudine
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 9 at risk

Adverse event: Hospitalization for Dehydration
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 9 at risk

Adverse event: Possible Neuro-Syphilis and Severe Hyponatremia
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 9 at risk

Adverse event: Acute Kidney Injury Secondary to Sepsis with Chest Focus
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 9 at risk

Adverse event: TB Meningitis with Moderate Hyponatremia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 9 at risk

Adverse event: Fever With Hyponatremia and Hypokalemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 11 at risk

Adverse event: Possible Aspiration Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 11 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 11 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 11 at risk

Adverse event: Possible Hypoglycemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 11 at risk

Adverse event: Grade 3 or 4 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Grade 3 or 4 hyponatremia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Sepsis Secondary to Multiple Pressure Sores
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Related to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Sepsis With Chest and Urinary Tract Focus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Sepsis With Acute Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Severe Sepsis Secondary to Multi-Drug Resistant Bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Grade 3 or 4 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Grade 3 or 4 hyponatremia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Grade 3 or 4 elevated total bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sepsis With Chest Focus Complicated with Acute Kidney Injury and Electrolyte Imbalance
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Severe Malaria with Severe Anemia and Urinary Tract Infection
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Severe Malaria and Severe Anemia
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Severe Sepsis with Skin Focus Possible Acute Pulmonary Embolus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Sepsis Secondary to Infected Decubitus Ulcer and Respiratory Failure Following Aspiration Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to Study Drug
Frequency: 1 affected / 10 at risk

Adverse event: Grade 3 or 4 anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Grade 3 or 4 hyponatremia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 10 at risk