Study: NCT01435265

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Abscess on R lower leg
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Elevated transaminases
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fall-Fractured clavicle and great toe
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hot and Cold Flashes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Intestinal abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Mild Hepatic Steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Orthostatic hypertension
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Productive cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Severe Itching
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sinus drainage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Abscess on L side
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Psychiatric Hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: hospitalization for mental abuse from spouse
Frequency: 1 affected / 3 at risk

Adverse event: Blurry/Double vision
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Elevated Blood sugar
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fibroid tumor
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Increased forehead wrinkling and perioral pigment changes
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain in L lower back radiating to L leg (muscle strain per PCP)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Possible Keratocanthoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Psoriatic arthropathy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Thickening of Cervical Lining
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Worsening of alopecia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: excessive drowsiness/sleepiness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: recurrent squamous cell carcinoma on R ventral forearm
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4 at risk