Study: NCT01511939

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Notes: Epistaxis resulting in hospitalization and blood transfusion; assessed by Principal Investigator as not related to Pennsaid because patient had a history of sinus surgery which has resulted in a history of occasional severe epistaxis.
Frequency: 1 affected / 9 at risk

Adverse event: Bowel Impaction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed by Principal Investigator as not related to Pennsaid
Frequency: 1 affected / 9 at risk

Adverse event: Swelling of lower extremities
Serious: no
Organ System: Vascular disorders
Notes: Assessed by Principal Investigator as possibly related to Pennsaid
Frequency: 1 affected / 9 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Notes: Assessed by Principal Investigator as not related to Pennsaid
Frequency: 1 affected / 9 at risk

Adverse event: Broken Tooth
Serious: no
Organ System: General disorders
Notes: Assessed by Principal Investigator as not related to Pennsaid
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed by Principal Investigator as possibly related to Pennsaid
Frequency: 1 affected / 9 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed by Principal Investigator as not related to Pennsaid
Frequency: 1 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed by Principal Investigator as not related to Pennsaid
Frequency: 1 affected / 9 at risk

Adverse event: Swelling of lower extremities
Serious: no
Organ System: Vascular disorders
Notes: Assessed by Principal Investigator as possibly related to Pennsaid
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Assessed by Principal Investigator as possibly related to Pennsaid
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed by Principal Investigator as not likely related to Pennsaid
Frequency: 1 affected / 10 at risk

Adverse event: Rash on lower extremities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Assessed by Principal Investigator as possibly related to Pennsaid
Frequency: 1 affected / 10 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Assessed by Principal Investigator as not related to Pennsaid
Frequency: 2 affected / 10 at risk

Adverse event: Metallic taste in mouth
Serious: no
Organ System: General disorders
Notes: Assessed by Principal Investigator as possibly related to Pennsaid
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Assessed by Principal Investigator as possibly related to Pennsaid
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Assessed by Principal Investigator as not likely related to Pennsaid
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed by Principal Investigator as not related to Pennsaid
Frequency: 1 affected / 10 at risk