Study: NCT01529268

Adverse event: Pain - Gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 88 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pain - abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 88 at risk

Adverse event: Ocular - other
Serious: no
Organ System: Eye disorders
Notes: Change in prescription
Frequency: 1 affected / 88 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 88 at risk

Adverse event: Mood alteration - anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 88 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 88 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 88 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 88 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 88 at risk

Adverse event: Teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 88 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Pain - head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 88 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 88 at risk

Adverse event: Pain - stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 88 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 88 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 88 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 88 at risk

Adverse event: Skin striae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection - skin
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection - urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 88 at risk

Adverse event: Mood alteration - irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection - ungual
Serious: no
Organ System: Infections and infestations
Notes: Nail infection
Frequency: 2 affected / 88 at risk

Adverse event: Hemorrhage - pulmonary - nose
Serious: no
Organ System: General disorders
Notes: Nosebleed
Frequency: 3 affected / 88 at risk

Adverse event: Pain - joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pain - chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 88 at risk

Adverse event: Hemorrhage, GU - vaginal
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 88 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Extremity - upper
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Metabolic/lab - other
Serious: no
Organ System: Endocrine disorders
Notes: Decrease in hemoglobin
Frequency: 1 affected / 88 at risk

Adverse event: Infection - pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Infection - stomach
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Irregular menses
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 88 at risk

Adverse event: Joint - function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Lumbar spine ROM
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Nasal/paranasal reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection - middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 88 at risk

Adverse event: Pain - middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 88 at risk

Adverse event: Pain - skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pain (extremity - limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 88 at risk

Adverse event: Pain - bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection (middle ear) with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection - upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Pulmonary - other (cold)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 88 at risk

Adverse event: Dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Edematous nodular lesions with pruritus
Frequency: 1 affected / 88 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 88 at risk

Adverse event: Dermatology - other (warts, HPV)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection (documented clinically) - pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Infection - lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Metabolic/lab - other
Serious: no
Organ System: Endocrine disorders
Notes: Worsening insulin resistance
Frequency: 1 affected / 88 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Neurology - other (concussion)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Intraop injury - liver
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Musculoskeletal - other (ankle sprain)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Musculoskeletal - other (wrist sprain)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Musculoskletal - other (spondylosis)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Infection - Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Mood alteration - depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 81 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 81 at risk

Adverse event: Soft tissue necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Pain - abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 81 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 81 at risk

Adverse event: Allergy - other
Serious: no
Organ System: Immune system disorders
Notes: Cat allergy
Frequency: 1 affected / 81 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 81 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 81 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 81 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 81 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 81 at risk

Adverse event: Pain - head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 81 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 81 at risk

Adverse event: Pain - stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 81 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 81 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Skin striae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Infection - skin
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 81 at risk

Adverse event: Pain - testicle
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 81 at risk

Adverse event: Infection - urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Mood alteration - not specified
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 81 at risk

Adverse event: Mood alteration - depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hemorrhage - pulmonary - nose
Serious: no
Organ System: General disorders
Notes: Nosebleed
Frequency: 4 affected / 81 at risk

Adverse event: Pain - chest/thorax NOS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Pain - breast
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 81 at risk

Adverse event: Metabolic/lab - other
Serious: no
Organ System: Hepatobiliary disorders
Notes: Increase in ALT and AST
Frequency: 1 affected / 81 at risk

Adverse event: Bone growth - spine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hemorrhage, GI - rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 81 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 81 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 81 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 81 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 81 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Infection - pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Infection - larynx
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Infection - stomach
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Joint - function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 81 at risk

Adverse event: Infection - middle ear (otitis media)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 81 at risk

Adverse event: Pain - middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 81 at risk

Adverse event: Pain - chest wall
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Pain (extremity - limb)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 81 at risk

Adverse event: Pain - bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 81 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Ocular - other
Serious: no
Organ System: Eye disorders
Notes: Periorbital cellulitis
Frequency: 1 affected / 81 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Infection (ungual) with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Infection (sinus) with unknown ANC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Infection - upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 81 at risk

Adverse event: Sexual - other (orchiopexy)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 81 at risk

Adverse event: Pulmonary - other (cold)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 81 at risk

Adverse event: Infection - bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Infection - sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 81 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 81 at risk

Adverse event: Pulmonary - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Positive PPD, negative chest X-ray
Frequency: 1 affected / 81 at risk

Adverse event: Joint - function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 81 at risk

Adverse event: Intraop injury - liver
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 81 at risk

Adverse event: Pain - throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 81 at risk

Adverse event: Dermatology - other
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Stepped on nail
Frequency: 1 affected / 81 at risk

Adverse event: Musculoskeletal - other (wrist sprain)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 81 at risk

Adverse event: Musculoskeletal - other (finger sprain)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 81 at risk

Adverse event: Cervical spine ROM
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 81 at risk

Adverse event: Tonsillectomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 81 at risk

Adverse event: Ocular - other (eye redness, allergies)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk