Study: NCT00112385

Adverse event: Partner Pregnant
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Post herpetic neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anxiety/Mood Alternation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Auditory/Ear-Other- Tingling in ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Burning sensation right foot
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dental/Teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Difficulty Swallowing
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Dryness inner eyelids
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Elevated Aldolase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Elevated CK
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Elevated GGT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Fall; Right Scalp Abrasion & Hematoma, R Chest Wall Bruising
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 11 at risk

Adverse event: Increased Muscle Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Increased weakness right lower leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Infection- Sacral area
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection NOS (Viral Syndrome)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection Upper Airway
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 11 at risk

Adverse event: Infection with Normal ANC - Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection with Normal - ANC - UTI
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection- Conjuctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Infection - Lip
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Interstital Lung Disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Laboratory/Other- Abnormal PAP Smear
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Low WBC Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Mechanics Hand on Right Index Finger- Hand/Foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal Pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pain- Ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 11 at risk

Adverse event: Post herpetic neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Skin/Cellulitus Right Great Toe
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Spinal Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Syndromes- Other (Sicca)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Transient Cardiac Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Hepatitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Worsening of Dermato
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Worsening Skin Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Dermatomyositis Flare
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal Distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Bleeding- Vaginal
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Edema: Left Knee Swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Elevated Aldolase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Elevated CK
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Elevated GGT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Elevated Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

Adverse event: Elevated WBC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fecal Urgency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 5 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Increased Edema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Increased Muscle Weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Infection Upper Airway
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Infection - Lip
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Infection - Other (Gastrointestinal)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Left Antecubital Fossa Scab- Wound Complication - Noninfectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Left Kidney Cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5 at risk

Adverse event: Musculoskeletal Pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Replacement of pacemaker
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 5 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5 at risk

Adverse event: Increased Vit D Level
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Pain- Throat/Pharynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Periungal Finger Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Skin Burn Left Forearm Vent Surface
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Subconjuctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Urine Glucose Pos.
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Urine Protein Pos.
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Vitamin D decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Worsening Skin Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk