Study: NCT01252966

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Squamous cell carcinoma was treated by surgical excision. The procedure was successful in removal of the Squamous Cell Carcinoma.
Frequency: 1 affected / 108 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Ppt admitted to the hospital due to a severe infection at the site of a root canal.
Frequency: 1 affected / 108 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Emergency Procedure
Serious: yes
Organ System: Surgical and medical procedures
Notes: PPT complaining of chest/neck pain. PPT was dx with CAD and underwent an emergency procedure to implant 2 stents.
Frequency: 1 affected / 108 at risk

Adverse event: Bowel Blockage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ppt was admitted to the hospital for treatment.
Frequency: 1 affected / 108 at risk

Adverse event: Collapsed Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 108 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 108 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 108 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 108 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 108 at risk

Adverse event: Disturbing Dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 108 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 108 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: PPT was dx. with Stage 4 Breast Cancer and underwent radiation tx.
Frequency: 1 affected / 105 at risk

Adverse event: Surgery (Gastric Bypass)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 105 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 105 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 105 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 105 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 105 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 105 at risk

Adverse event: Disturbing Dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 105 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 105 at risk