Study: NCT03617458

Adverse event: Intravenous Medication Line Malfunction/Infection
Serious: yes
Organ System: Product Issues
Notes: Any issue with the Hickman Catheter that caused hospitalization was considered serious but non-related.
Frequency: 4 affected / 18 at risk

Adverse event: Clinical Worsening
Serious: yes
Organ System: General disorders
Notes: Related to routine Catheter procedure. Deemed non-study relatable.
Frequency: 1 affected / 18 at risk

Adverse event: Gastrointestinal Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Including issues like bloating, nausea, diarrhea, or discomfort. Deemed not to be serious events
Frequency: 8 affected / 18 at risk

Adverse event: General Infection
Serious: no
Organ System: General disorders
Notes: This included not relatable or serious adverse conditions such as cellulitis or general sore throat.
Frequency: 1 affected / 18 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Deemed not study related.
Frequency: 1 affected / 17 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Deemed Non-study Related
Frequency: 1 affected / 17 at risk

Adverse event: Infections requiring Hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: Included two events,one with pneumonia and one with an upper respiratory infection. Both deemed not-relatable.
Frequency: 1 affected / 17 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Bleed was deemed non-study related.
Frequency: 1 affected / 17 at risk

Adverse event: Gastrointestinal Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Including issues like bloating, nausea, diarrhea, or discomfort. Deemed not to be serious events
Frequency: 3 affected / 17 at risk

Adverse event: Intravenous Medication Line Malfunction/Infection
Serious: no
Organ System: Product Issues
Notes: Deemed not serious or relatable.
Frequency: 2 affected / 17 at risk

Adverse event: Common Pulmonary Hypertension Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Complications are expected in patient population considering pulmonary hypertension diagnosis. Unrelated to study and expected.
Frequency: 1 affected / 17 at risk

Adverse event: General Infection
Serious: no
Organ System: General disorders
Notes: This included not relatable or serious adverse conditions such as cellulitis or general sore throat.
Frequency: 1 affected / 17 at risk

Adverse event: Infections requiring Hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: Included two events,one with pneumonia and one with an upper respiratory infection. Both deemed not-relatable.
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Including issues like bloating, nausea, diarrhea, or discomfort. Deemed not to be serious events
Frequency: 10 affected / 19 at risk

Adverse event: Intravenous Medication Line Malfunction/Infection
Serious: no
Organ System: Product Issues
Notes: Deemed not serious or relatable.
Frequency: 1 affected / 19 at risk

Adverse event: Common Pulmonary Hypertension Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Complications are expected in patient population considering pulmonary hypertension diagnosis. Unrelated to study and expected.
Frequency: 2 affected / 19 at risk

Adverse event: General Infection
Serious: no
Organ System: General disorders
Notes: This included not relatable or serious adverse conditions such as cellulitis or general sore throat.
Frequency: 1 affected / 19 at risk

Adverse event: Supraventriculartachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Resulted in hospitalizations but deemed not relatable.
Frequency: 1 affected / 19 at risk

Adverse event: Gastrointestinal Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Including issues like bloating, nausea, diarrhea, or discomfort. Deemed not to be serious events
Frequency: 3 affected / 19 at risk

Adverse event: Intravenous Medication Line Malfunction/Infection
Serious: no
Organ System: Product Issues
Notes: Deemed not serious or relatable.
Frequency: 1 affected / 19 at risk

Adverse event: Common Pulmonary Hypertension Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Complications are expected in patient population considering pulmonary hypertension diagnosis. Unrelated to study and expected.
Frequency: 5 affected / 19 at risk

Adverse event: General Infection
Serious: no
Organ System: General disorders
Notes: This included not relatable or serious adverse conditions such as cellulitis or general sore throat.
Frequency: 1 affected / 19 at risk