Study: NCT00130637

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: palpitations with normal echocardiogram (ECG), patient hospitalized for observation
Frequency: 1 affected / 6 at risk

Adverse event: herpes zoster skin infection
Serious: no
Organ System: Infections and infestations
Notes: Verbatim event description reported by site staff was "maculopapular rash (positive for varicella virus)"
Frequency: 1 affected / 6 at risk

Adverse event: lower extremity edema
Serious: no
Organ System: General disorders
Notes: Verbatim event description reported by site staff was "bilateral ankle swelling and associating pain". This event was secondary to naproxen as it resolved upon discontinuation of naproxen
Frequency: 1 affected / 6 at risk

Adverse event: Allergy symptoms
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Aphtous ulcer on right lower gum
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Bilateral Hand and wrists inflammation, Mild Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cold Symptoms/Sore throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Decreased appetite with associated nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Decreased Hgb and Hct
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 6 at risk

Adverse event: Elevated Cholesterol level
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Elevated CPK
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Elevated ESR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Elevated potassium level
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Elevated Urine WBC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Elevated WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Erythematous area of Lower Eyelid
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Gingival abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headaches/Back Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Low Hgb and Hct
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Low White Blood Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mild myalgia in legs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mild pain left knee and hip after playing soccer.
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: mild right shoulder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mild shoulder pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mouth Sores
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mucous membrane Ulcers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasal congestion causing right ear pain
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Neck and Lower back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Occasional dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Occasional Light headiness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pain Right great toe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Painful Right Wrist
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Photophobia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Planter tenderness
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pustules over abdominal area
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Right knee pain without inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Right Thumb sore and swollen
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Right Knee Pain few hrs after prolonged exertion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Ruptured blister inner lower lip
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Infections and infestations
Notes: Verbatim event description reported by site staff was "scabies, rash chest, under arms and inner thighs"
Frequency: 1 affected / 6 at risk

Adverse event: Slight increase in total bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Slightly Swollen right anterior pilla of tonsil
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sore Throat, fever, body ache
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Sore Throat, Low grade fever, Malaise
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Squinting OU
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Stuffy Nose and Sore Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Systemic Joint Inflammation, & assoc. joint pain.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Tonsilitis with associated fever
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Slight Leukocyte esterase increase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Slight cold
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk