Study: NCT04057820

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE during main study in-hospital prior to discharge.
Frequency: 1 affected / 702 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 702 at risk

Adverse event: Accidental Drug Ingestion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 702 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported after discharge from hospital.
Frequency: 2 affected / 702 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 702 at risk

Adverse event: Severe Weight Loss
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE during main study in-hospital prior to discharge.
Frequency: 5 affected / 702 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Notes: AE during main study in-hospital prior to discharge.
Frequency: 1 affected / 702 at risk

Adverse event: Diaper Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE during main study after hospital discharge.
Frequency: 1 affected / 702 at risk

Adverse event: Non-accidental trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: AE during main study after hospital discharge.
Frequency: 1 affected / 702 at risk

Adverse event: PCP suspected resp. distress, not confirmed by ED
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: AE during main study after hospital discharge.
Frequency: 1 affected / 702 at risk

Adverse event: Severe Weight Loss
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE during main study in-hospital prior to discharge.
Frequency: 2 affected / 603 at risk

Adverse event: Accidental trauma (infant dropped)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE during main study in-hospital prior to discharge.
Frequency: 1 affected / 603 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Abnormal echocardiogram
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Acute Covid-19
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Tachypnea required readmission to hospital
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Vomiting R11.10
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Observation and evaluation of newborn sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Severe Weight Loss
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE reported after discharge from hospital.
Frequency: 1 affected / 603 at risk

Adverse event: Severe Weight Loss
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: AE during main study in-hospital prior to discharge.
Frequency: 12 affected / 603 at risk

Adverse event: Accidental trauma (infant dropped)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: AE during main study in-hospital prior to discharge.
Frequency: 1 affected / 603 at risk

Adverse event: Cytomegalovirus test
Serious: no
Organ System: Infections and infestations
Notes: AE during main study in-hospital prior to discharge.
Frequency: 2 affected / 603 at risk

Adverse event: Fall, caught before hitting floor
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: AE during main study in-hospital prior to discharge.
Frequency: 1 affected / 603 at risk

Adverse event: Frequent emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE during main study after hospital discharge.
Frequency: 1 affected / 603 at risk

Adverse event: Neonatal sleep myoclonus
Serious: no
Organ System: Nervous system disorders
Notes: AE during main study after hospital discharge.
Frequency: 1 affected / 603 at risk

Adverse event: Attention to g-tube
Serious: no
Organ System: Gastrointestinal disorders
Notes: AE during main study after hospital discharge.
Frequency: 1 affected / 603 at risk