Study: NCT00119067

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 259 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: stage 1A
Frequency: 1 affected / 259 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 259 at risk

Adverse event: cellulitis, hospitalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 259 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 259 at risk

Adverse event: miscarriage/spontaneous abortion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 259 at risk

Adverse event: Ceasarian section with healthy infant delivery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 259 at risk

Adverse event: Chronic hepatitis B
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 259 at risk

Adverse event: Hospitalized for mental disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: to include bipolar disorder, psychosis, anxiety, depression, suicidal ideations
Frequency: 3 affected / 259 at risk

Adverse event: Mammoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 259 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 259 at risk

Adverse event: head injury following motor vehicle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: to include concussion and brain injury/coma
Frequency: 1 affected / 259 at risk

Adverse event: corneal ulcer/iritis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 259 at risk

Adverse event: delivery of healthy twins
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: one vaginal, one via C-section
Frequency: 1 affected / 259 at risk

Adverse event: ventral hernia and repair
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 259 at risk

Adverse event: atrial Fibrillation secondary to Mitral Valve Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Hospitalized; non-specific symptoms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 259 at risk

Adverse event: pituitary mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 259 at risk

Adverse event: post surgical complications
Serious: yes
Organ System: Surgical and medical procedures
Notes: to include infection, pain at site, nausea/vomiting/constipation
Frequency: 2 affected / 259 at risk

Adverse event: intrarenal malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 259 at risk

Adverse event: cardioconversion to correct atrial flutter with supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 259 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 259 at risk

Adverse event: panniculectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 259 at risk

Adverse event: Nephrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 259 at risk

Adverse event: Mitral valve replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 259 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: to include heavy menses and pelvic pain
Frequency: 1 affected / 259 at risk

Adverse event: Prostatectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: to remove prostate cancer
Frequency: 1 affected / 259 at risk

Adverse event: gastroesophageal reflux leading to abnormal EKG and chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 259 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 259 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 259 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 259 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 259 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 259 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 259 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 259 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 259 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 199 affected / 259 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 150 affected / 259 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 244 affected / 259 at risk

Adverse event: Injection site joint movement impairment
Serious: no
Organ System: General disorders
Frequency: 163 affected / 259 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 226 affected / 259 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 186 affected / 259 at risk

Adverse event: INJECTION SITE SWELLING / LUMP
Serious: no
Organ System: General disorders
Frequency: 248 affected / 259 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 251 affected / 259 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 223 affected / 259 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 259 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 259 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 259 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 259 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 259 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 259 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 259 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 259 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 259 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 259 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 259 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 259 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 259 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 259 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 197 affected / 259 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 259 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 259 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 259 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 203 affected / 259 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 259 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 259 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 259 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 22 affected / 259 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 259 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 259 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 259 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 259 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 259 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 259 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 259 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 259 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 259 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 259 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 259 at risk

Adverse event: Death due to atherosclerosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hydrocephalus and aqueductal stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: new onset of seizure led to diagnosis of hydrocephalus
Frequency: 1 affected / 262 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 262 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 262 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 262 at risk

Adverse event: cellulitis, hospitalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 262 at risk

Adverse event: appendectomy secondary to appendicitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Nervous system disorders
Notes: secondary to accidents (MVA, bicycle)
Frequency: 1 affected / 262 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 262 at risk

Adverse event: Ceasarian section with healthy infant delivery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 262 at risk

Adverse event: surgical repair of cystocele, vaginocele, rectocele
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Kidney Stone(s)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Vascular graft
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: Hospitalized for alcohol dependence/rehabilitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 262 at risk

Adverse event: Angioplasty and stent placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: secondary to fibroids and benign ovarian cyst
Frequency: 1 affected / 262 at risk

Adverse event: bone fracture(s) following accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: motor vehicle, bicycle, boat
Frequency: 1 affected / 262 at risk

Adverse event: injury after falling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: fracture or soft tissue
Frequency: 2 affected / 262 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Cardiac disorders
Notes: bacterial endocarditis (Enterococcus); persistent; weight loss and skin rash secondary to condition; led to cardiac failure and surgery (listed under "surgical procedures")
Frequency: 1 affected / 262 at risk

Adverse event: Hospitalized for mental disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: to include bipolar disorder, psychosis, anxiety, depression, suicidal ideations
Frequency: 4 affected / 262 at risk

Adverse event: cardiac catheritization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: head injury following motor vehicle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: to include concussion and brain injury/coma
Frequency: 1 affected / 262 at risk

Adverse event: death due to suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 262 at risk

Adverse event: death following motor vehicle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: head injury
Frequency: 1 affected / 262 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 262 at risk

Adverse event: dehydration secondary to other cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 262 at risk

Adverse event: Oesophageal rupture
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Esophageal-gastro-duodenoscopy to repair
Frequency: 1 affected / 262 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 262 at risk

Adverse event: syncope with hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 262 at risk

Adverse event: hysterectomy and salpingooophorectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: laminectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 262 at risk

Adverse event: Partial paralysis following gunshot wound to head
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 262 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 262 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: cellulitis, not hospitalized
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 262 at risk

Adverse event: Mitral valve replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Aortic valve replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: removal of vegetations due to endocarditis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 262 at risk

Adverse event: Ventricular cisternostomy
Serious: yes
Organ System: Nervous system disorders
Notes: for aqueductal stenosis
Frequency: 1 affected / 262 at risk

Adverse event: benign ovarian cysts
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 262 at risk

Adverse event: hysterectomy plus oophorectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 262 at risk

Adverse event: multiple injuries following motor vehicle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: to include fractures, coma, and cardiac arrest. Patient ultimately survived injuries
Frequency: 1 affected / 262 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 262 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 262 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 262 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 262 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 262 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 262 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 262 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 262 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 187 affected / 262 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 101 affected / 262 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 209 affected / 262 at risk

Adverse event: Injection site joint movement impairment
Serious: no
Organ System: General disorders
Frequency: 179 affected / 262 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 223 affected / 262 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 114 affected / 262 at risk

Adverse event: INJECTION SITE SWELLING / LUMP
Serious: no
Organ System: General disorders
Frequency: 215 affected / 262 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 241 affected / 262 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 154 affected / 262 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 262 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 262 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 262 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 262 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 262 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 262 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 262 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 262 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 262 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 262 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 262 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 262 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 262 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 262 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 185 affected / 262 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 262 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 262 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 262 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 173 affected / 262 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 262 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 262 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 262 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 262 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 262 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 262 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 262 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 262 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 262 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 262 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 262 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 262 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 262 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 262 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 262 at risk

Adverse event: muscle, tendon, or ligament tear/rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Due to falls, accidents, or non-specified reasons
Frequency: 1 affected / 256 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 256 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 256 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 256 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 256 at risk

Adverse event: cellulitis, hospitalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Embolization secondary to AV malformation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 256 at risk

Adverse event: Ceasarian section with healthy infant delivery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 256 at risk

Adverse event: meningitis (viral)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 256 at risk

Adverse event: Acoustic neuroma
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 256 at risk

Adverse event: staph infection secondary to poison ivy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Thyroidectomy secondary to thyroid papillary carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 256 at risk

Adverse event: Hospitalized for mental disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: to include bipolar disorder, psychosis, anxiety, depression, suicidal ideations
Frequency: 1 affected / 256 at risk

Adverse event: blood clot
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 256 at risk

Adverse event: hospitalized for drug overdose
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 256 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 256 at risk

Adverse event: death due to fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 256 at risk

Adverse event: delivery of infant with right club foot deformity
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 256 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 256 at risk

Adverse event: hypothyroid following radioactive idodine treatment for Graves' disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 256 at risk

Adverse event: hysterectomy and salpingooophorectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 256 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 256 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: uncontrolled diabetes and syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 256 at risk

Adverse event: Breast conserving surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: secondary to breast cancer
Frequency: 1 affected / 256 at risk

Adverse event: Colectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: for colon cancer
Frequency: 1 affected / 256 at risk

Adverse event: pacemaker implatation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 256 at risk

Adverse event: lumpectomy/mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 256 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: to include heavy menses and pelvic pain
Frequency: 1 affected / 256 at risk

Adverse event: benign ovarian cysts
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 256 at risk

Adverse event: Leiomyomata
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 256 at risk

Adverse event: Adenomyosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 256 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 256 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 256 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 256 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 256 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 256 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 256 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 256 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 256 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 187 affected / 256 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 85 affected / 256 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 207 affected / 256 at risk

Adverse event: Injection site joint movement impairment
Serious: no
Organ System: General disorders
Frequency: 177 affected / 256 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 224 affected / 256 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 101 affected / 256 at risk

Adverse event: INJECTION SITE SWELLING / LUMP
Serious: no
Organ System: General disorders
Frequency: 218 affected / 256 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 243 affected / 256 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 140 affected / 256 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 256 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 13 affected / 256 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 256 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 256 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 256 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 256 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 256 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 256 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 256 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 256 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 256 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 256 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 256 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 256 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 188 affected / 256 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 256 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 256 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 256 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 194 affected / 256 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 256 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 256 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 256 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 27 affected / 256 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 256 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 256 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 256 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 256 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 256 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 256 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 256 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 256 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 256 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 256 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 256 at risk

Adverse event: muscle, tendon, or ligament tear/rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Due to falls, accidents, or non-specified reasons
Frequency: 2 affected / 258 at risk

Adverse event: Generalized allergic reaction
Serious: yes
Organ System: Immune system disorders
Notes: Generalized allergic reaction (note:

Contac Nighttime medicine was also temporally associated with some of the allergic symptoms. These symptoms reoccurred following a second exposure to Contac Nighttime medicine)
Frequency: 1 affected / 258 at risk

Adverse event: Pneumocystis carinii
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 258 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 258 at risk

Adverse event: cellulitis, hospitalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 258 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 258 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 258 at risk

Adverse event: burns
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: following a fire
Frequency: 1 affected / 258 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 258 at risk

Adverse event: Systemic Lupus Erythematosus/positive ANA
Serious: yes
Organ System: Immune system disorders
Notes: and lupus related disease
Frequency: 1 affected / 258 at risk

Adverse event: miscarriage/spontaneous abortion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 258 at risk

Adverse event: Ceasarian section with healthy infant delivery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 258 at risk

Adverse event: Kidney Stone(s)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 258 at risk

Adverse event: Vascular graft
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: bone fracture(s) following accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: motor vehicle, bicycle, boat
Frequency: 4 affected / 258 at risk

Adverse event: lumbar diskectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: secondary to bilateral lumbar radiculopathy
Frequency: 1 affected / 258 at risk

Adverse event: cardiac catheritization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 258 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 258 at risk

Adverse event: C-section; infant with hydrocephalus and jaundice
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 258 at risk

Adverse event: c-section; infant with jaundice
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 258 at risk

Adverse event: death due to gunshot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 258 at risk

Adverse event: dehydration secondary to other cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 258 at risk

Adverse event: Abdominoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 258 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 258 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 258 at risk

Adverse event: possible multiple sclerosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 258 at risk

Adverse event: Laparoscopic Lyses of Adhesions due to intestinal obstructions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 258 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 258 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 258 at risk

Adverse event: spleen laceration following motor vehicle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 258 at risk

Adverse event: cardioconversion to correct atrial flutter with supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Pancreatectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 258 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: 2:1
Frequency: 1 affected / 258 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: to include heavy menses and pelvic pain
Frequency: 1 affected / 258 at risk

Adverse event: vertebral fusion
Serious: yes
Organ System: Surgical and medical procedures
Notes: cervical or lumbar
Frequency: 1 affected / 258 at risk

Adverse event: Prostatectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: to remove prostate cancer
Frequency: 1 affected / 258 at risk

Adverse event: HIV test positive
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 258 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 258 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 258 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 258 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 258 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 258 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 258 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 258 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 258 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 177 affected / 258 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 101 affected / 258 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 187 affected / 258 at risk

Adverse event: Injection site joint movement impairment
Serious: no
Organ System: General disorders
Frequency: 176 affected / 258 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 221 affected / 258 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 71 affected / 258 at risk

Adverse event: INJECTION SITE SWELLING / LUMP
Serious: no
Organ System: General disorders
Frequency: 200 affected / 258 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 237 affected / 258 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 122 affected / 258 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 258 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 258 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 258 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 59 affected / 258 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 258 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 258 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 258 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 258 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 258 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 258 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 258 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 258 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 258 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 258 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 186 affected / 258 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 258 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 258 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 258 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 181 affected / 258 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 258 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 258 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 258 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 17 affected / 258 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 258 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 258 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 258 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 258 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 258 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 258 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 258 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 258 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 258 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 258 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 258 at risk

Adverse event: muscle, tendon, or ligament tear/rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Due to falls, accidents, or non-specified reasons
Frequency: 3 affected / 268 at risk

Adverse event: Bilateral pseudotumor cerebri
Serious: yes
Organ System: Nervous system disorders
Notes: occurred with bilateral disc edema
Frequency: 1 affected / 268 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 268 at risk

Adverse event: cellulitis, hospitalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 268 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: appendectomy secondary to appendicitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 268 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Systemic Lupus Erythematosus/positive ANA
Serious: yes
Organ System: Immune system disorders
Notes: and lupus related disease
Frequency: 1 affected / 268 at risk

Adverse event: miscarriage/spontaneous abortion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 268 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Ceasarian section with healthy infant delivery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 268 at risk

Adverse event: premature labor; delivery of healthy infant
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 268 at risk

Adverse event: Vascular graft
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hospitalized for alcohol dependence/rehabilitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 268 at risk

Adverse event: Thyroidectomy secondary to thyroid papillary carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: bone fracture(s) following accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: motor vehicle, bicycle, boat
Frequency: 1 affected / 268 at risk

Adverse event: injury after falling
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: fracture or soft tissue
Frequency: 1 affected / 268 at risk

Adverse event: benign ovarian teratoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Hospitalized for mental disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: to include bipolar disorder, psychosis, anxiety, depression, suicidal ideations
Frequency: 1 affected / 268 at risk

Adverse event: blood clot
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 268 at risk

Adverse event: GI ulcers and bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: possible C.difficile
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: post surgical complications
Serious: yes
Organ System: Surgical and medical procedures
Notes: to include infection, pain at site, nausea/vomiting/constipation
Frequency: 1 affected / 268 at risk

Adverse event: Laparoscopic Lyses of Adhesions due to intestinal obstructions
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 268 at risk

Adverse event: shoulder impingement and correction
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 268 at risk

Adverse event: sinus reconstruction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 268 at risk

Adverse event: vertebral fusion
Serious: yes
Organ System: Surgical and medical procedures
Notes: cervical or lumbar
Frequency: 1 affected / 268 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 268 at risk

Adverse event: HIV test positive
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: hospitalized; chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: transient ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 268 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 268 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 268 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 268 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 268 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 268 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 268 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 268 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 181 affected / 268 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 80 affected / 268 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 195 affected / 268 at risk

Adverse event: Injection site joint movement impairment
Serious: no
Organ System: General disorders
Frequency: 188 affected / 268 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 222 affected / 268 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 73 affected / 268 at risk

Adverse event: INJECTION SITE SWELLING / LUMP
Serious: no
Organ System: General disorders
Frequency: 184 affected / 268 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 244 affected / 268 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 106 affected / 268 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 268 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 268 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 268 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 268 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 268 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 268 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 268 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 268 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 268 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 268 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 268 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 52 affected / 268 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 268 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 268 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 195 affected / 268 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 268 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 268 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 268 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 187 affected / 268 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 268 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 268 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 268 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 30 affected / 268 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 268 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 268 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 268 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 268 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 268 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 268 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 268 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 268 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 268 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 268 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 268 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 260 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 260 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 260 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: appendectomy secondary to appendicitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 260 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 260 at risk

Adverse event: Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 260 at risk

Adverse event: acute psychosis and schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 260 at risk

Adverse event: Hospitalized for mental disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: to include bipolar disorder, psychosis, anxiety, depression, suicidal ideations
Frequency: 4 affected / 260 at risk

Adverse event: head injury following motor vehicle accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: to include concussion and brain injury/coma
Frequency: 1 affected / 260 at risk

Adverse event: hospitalized for drug overdose
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 260 at risk

Adverse event: c-section; delivery of infant with bilateral congenital hip dysplasia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 260 at risk

Adverse event: death secondary to AIDS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 260 at risk

Adverse event: death due to aneurnysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 260 at risk

Adverse event: Abdominoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: GI ulcers and bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: ventral hernia and repair
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 260 at risk

Adverse event: hysterectomy and salpingooophorectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: laminectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 260 at risk

Adverse event: Stage IV Non Hodgkins Lymphoma, B cell intermediate grade
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 260 at risk

Adverse event: metastasis of pancreatic adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 260 at risk

Adverse event: pacemaker implatation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: Pancreatectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: lumpectomy/mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: panniculectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 260 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: to include heavy menses and pelvic pain
Frequency: 1 affected / 260 at risk

Adverse event: avascular necrosis of hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: secondary to chemotherapy and steroids
Frequency: 1 affected / 260 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: due to avascular necrosis
Frequency: 1 affected / 260 at risk

Adverse event: hospitalized, back pain evaluation
Serious: yes
Organ System: General disorders
Notes: no diagnosis provided
Frequency: 1 affected / 260 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 260 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 260 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 260 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 260 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 260 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 260 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 260 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 260 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 158 affected / 260 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 74 affected / 260 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 137 affected / 260 at risk

Adverse event: Injection site joint movement impairment
Serious: no
Organ System: General disorders
Frequency: 42 affected / 260 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 84 affected / 260 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 32 affected / 260 at risk

Adverse event: INJECTION SITE SWELLING / LUMP
Serious: no
Organ System: General disorders
Frequency: 120 affected / 260 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 110 affected / 260 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 36 affected / 260 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 260 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 260 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 260 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 260 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 260 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 260 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 260 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 260 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 260 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 260 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 260 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 260 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 260 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 260 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 130 affected / 260 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 260 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 260 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 260 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 177 affected / 260 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 260 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 260 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 260 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 25 affected / 260 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 260 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 260 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 260 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 260 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 260 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 260 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 260 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 260 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 260 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 260 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 260 at risk