Study: NCT02968849

Adverse event: Any Event in SOC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Tympanic membrane perforation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Electrocution
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Peripheral swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 2704 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Genital abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Paronychia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 42 affected / 2704 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Back injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Chemical poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2704 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2704 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Limb traumatic amputation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Snake bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Soft tissue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Stab wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 2704 at risk

Adverse event: Tendon injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Traumatic haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 2704 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Mixed connective tissue disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 2704 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 2704 at risk

Adverse event: Abortion incomplete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2704 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 2704 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 2704 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2704 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2704 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2704 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 2704 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Intentional self-injury
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Schizoaffective disorder bipolar type
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Stress
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Substance-induced psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Female reproductive tract disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Hypertensive urgency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 2704 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 2704 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 2704 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 2704 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 2704 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Periorbital swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Swelling of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 151 affected / 2704 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 2704 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 2704 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 2704 at risk

Adverse event: Angular cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Breath odour
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 2704 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 2704 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 2704 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 2704 at risk

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 2704 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2704 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Lip swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 2704 at risk

Adverse event: Peptic ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Proctitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Rectal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Tooth impacted
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 2704 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: General disorders
Frequency: 206 affected / 2704 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 2704 at risk

Adverse event: Hangover
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 166 affected / 2704 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 21 affected / 2704 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Injection site ulcer
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Anti-neutrophil cytoplasmic antibody positive vasculitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Infections and infestations
Frequency: 1243 affected / 2704 at risk

Adverse event: Abdominal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Abdominal wall abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Abscess jaw
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 2704 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 2704 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Bacterial urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 2704 at risk

Adverse event: Bartholin's abscess
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 2704 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2704 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Chest wall abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 2704 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Ecthyma
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Endometritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Extrapulmonary tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 2704 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 2704 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 2704 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 2704 at risk

Adverse event: Genital abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Genital herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Genital herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Genital ulcer syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 2704 at risk

Adverse event: Genitourinary chlamydia infection
Serious: no
Organ System: Infections and infestations
Frequency: 661 affected / 2704 at risk

Adverse event: Genitourinary tract gonococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 286 affected / 2704 at risk

Adverse event: Genitourinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Groin abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 2704 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Injection site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Latent syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Lice infestation
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 2704 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 2704 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 2704 at risk

Adverse event: Orchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2704 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Pelvic abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Pelvic inflammatory disease
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 2704 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 2704 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Proctitis chlamydial
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 2704 at risk

Adverse event: Proctitis gonococcal
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 2704 at risk

Adverse event: Pulmonary tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Pustule
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 2704 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 2704 at risk

Adverse event: Schistosomiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Secondary syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Sexually transmitted disease
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 2704 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 2704 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 2704 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 2704 at risk

Adverse event: Syphilis genital
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Tinea capitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Tinea cruris
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Tinea faciei
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 2704 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 2704 at risk

Adverse event: Tonsillitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 131 affected / 2704 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 2704 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 2704 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2704 at risk

Adverse event: Urogenital trichomoniasis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 2704 at risk

Adverse event: Vaginitis chlamydial
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 2704 at risk

Adverse event: Varicella zoster virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2704 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Viral sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Viral tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 2704 at risk

Adverse event: Vulval abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 2704 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Vulvovaginitis chlamydial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Vulvovaginitis gonococcal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2704 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 150 affected / 2704 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 118 affected / 2704 at risk

Adverse event: Alcohol poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 2704 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Burns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Chest injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Eye contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 2704 at risk

Adverse event: First degree chemical burn of skin
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Forearm fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Foreign body in ear
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Genital contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Gun shot wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2704 at risk

Adverse event: Herbal toxicity
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Human bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2704 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 2704 at risk

Adverse event: Ligament injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 2704 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 2704 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Multiple injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2704 at risk

Adverse event: Neck injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Penis injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Periorbital haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2704 at risk

Adverse event: Procedural vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 2704 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 2704 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2704 at risk

Adverse event: Stab wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2704 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 2704 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Investigations
Frequency: 92 affected / 2704 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2704 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 47 affected / 2704 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 2704 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 2704 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 2704 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 2704 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 2704 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 2704 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 90 affected / 2704 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 2704 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Axillary mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 2704 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 2704 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 2704 at risk

Adverse event: Neck mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 2704 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 2704 at risk

Adverse event: Soft tissue mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 2704 at risk

Adverse event: Anogenital warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 2704 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2704 at risk

Adverse event: Neoplasm skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2704 at risk

Adverse event: Penile wart
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 2704 at risk

Adverse event: Vulvovaginal warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Nervous system disorders
Frequency: 165 affected / 2704 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 2704 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 117 affected / 2704 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Migraine with aura
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Motor dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 2704 at risk

Adverse event: Acute stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 2704 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Loss of libido
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Premature ejaculation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Substance-induced mood disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Substance-induced psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 2704 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Ketonuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 2704 at risk

Adverse event: Urethral discharge
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Urethral syndrome
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 167 affected / 2704 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Breast haematoma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Cervical cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Coital bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Abnormal uterine bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Galactorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Genital pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Genital rash
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Genital ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 2704 at risk

Adverse event: Penile blister
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Penile discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Polycystic ovaries
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 134 affected / 2704 at risk

Adverse event: Vulval ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Vulvovaginal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 2704 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 2704 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 2704 at risk

Adverse event: Nasal polyps
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 2704 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 2704 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 136 affected / 2704 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 2704 at risk

Adverse event: Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 2704 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 2704 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 2704 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Hidradenitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Lipohypertrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 2704 at risk

Adverse event: Pseudofolliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 2704 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 2704 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 2704 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 2704 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2704 at risk

Adverse event: Solar dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 2704 at risk

Adverse event: Victim of sexual abuse
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 2704 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 2704 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2704 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2704 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Anaemia of pregnancy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 2700 at risk

Adverse event: Alcoholic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Pancreatic pseudocyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 2700 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Acute hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Appendiceal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Central nervous system infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Meningitis tuberculous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 38 affected / 2700 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Chest injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Face injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Peripancreatic fluid collection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Soft tissue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Stab wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 2700 at risk

Adverse event: Tendon injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Traumatic haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2700 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 2700 at risk

Adverse event: Anogenital warts
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 2700 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 2700 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2700 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 2700 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2700 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2700 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2700 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2700 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 12 affected / 2700 at risk

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Acute stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Intentional self-injury
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Substance-induced psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Pneumothorax spontaneous
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 2700 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Graves' disease
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 2700 at risk

Adverse event: Atopic keratoconjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 2700 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Periorbital pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Photokeratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 162 affected / 2700 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 2700 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 2700 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Anal pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 2700 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 2700 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 2700 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 2700 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 2700 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Lip swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Mouth cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 2700 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 2700 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: General disorders
Frequency: 198 affected / 2700 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 2700 at risk

Adverse event: Hernia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 171 affected / 2700 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Injection site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Infections and infestations
Frequency: 1295 affected / 2700 at risk

Adverse event: Abdominal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Abdominal wall infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 2700 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 2700 at risk

Adverse event: Acute hepatitis B
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Anal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 2700 at risk

Adverse event: Bartholin's abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 2700 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 2700 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 2700 at risk

Adverse event: Cestode infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Chronic hepatitis B
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Chronic sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 2700 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Dysentery
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Extrapulmonary tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 2700 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 2700 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2700 at risk

Adverse event: Gastritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 53 affected / 2700 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 2700 at risk

Adverse event: Genital herpes
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Genital infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Genital ulcer syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 2700 at risk

Adverse event: Genitourinary chlamydia infection
Serious: no
Organ System: Infections and infestations
Frequency: 689 affected / 2700 at risk

Adverse event: Genitourinary tract gonococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 272 affected / 2700 at risk

Adverse event: Genitourinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2700 at risk

Adverse event: Gonococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Implant site abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Implant site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 2700 at risk

Adverse event: Injection site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Joint abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Lice infestation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 2700 at risk

Adverse event: Lymphogranuloma venereum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Male genital tract tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Nasal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 2700 at risk

Adverse event: Omphalitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Oral pustule
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Orchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2700 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2700 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Otitis media bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Pelvic inflammatory disease
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 2700 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 2700 at risk

Adverse event: Proctitis chlamydial
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 2700 at risk

Adverse event: Proctitis gonococcal
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 2700 at risk

Adverse event: Pulmonary tuberculosis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 2700 at risk

Adverse event: Pustule
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 2700 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 2700 at risk

Adverse event: Schistosomiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Secondary syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Sexually transmitted disease
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Skin bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 2700 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 2700 at risk

Adverse event: Syphilis genital
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Tinea cruris
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Tinea versicolour
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 2700 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 2700 at risk

Adverse event: Tonsillitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 119 affected / 2700 at risk

Adverse event: Upper respiratory tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 2700 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 2700 at risk

Adverse event: Urinary tract infection bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 2700 at risk

Adverse event: Urogenital trichomoniasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Vaginitis chlamydial
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Vestibulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 2700 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 2700 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Viral sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Viral tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 2700 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 2700 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 2700 at risk

Adverse event: Vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Vulvovaginitis trichomonal
Serious: no
Organ System: Infections and infestations
Frequency: 165 affected / 2700 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 2700 at risk

Adverse event: Wound sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 80 affected / 2700 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2700 at risk

Adverse event: Chest injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2700 at risk

Adverse event: Eye contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 2700 at risk

Adverse event: Fibula fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Gun shot wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Human bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2700 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2700 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 2700 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 2700 at risk

Adverse event: Post procedural contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2700 at risk

Adverse event: Procedural vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2700 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 2700 at risk

Adverse event: Soft tissue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 2700 at risk

Adverse event: Stab wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 2700 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 2700 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Investigations
Frequency: 95 affected / 2700 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2700 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2700 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 53 affected / 2700 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2700 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2700 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 2700 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 2700 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 2700 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 98 affected / 2700 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 2700 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Axillary mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 2700 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Fracture pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 2700 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 2700 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 2700 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Polyarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Soft tissue swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 2700 at risk

Adverse event: Anogenital warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 2700 at risk

Adverse event: Fibroadenoma of breast
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Penile wart
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Uterine leiomyoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Vulvovaginal warts
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Nervous system disorders
Frequency: 151 affected / 2700 at risk

Adverse event: Cluster headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 2700 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 107 affected / 2700 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Radial nerve palsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 2700 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2700 at risk

Adverse event: Device expulsion
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 2700 at risk

Adverse event: Acute stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 2700 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Generalised anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Post-traumatic stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 2700 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 2700 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Lower urinary tract symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 2700 at risk

Adverse event: Urethral discharge
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 176 affected / 2700 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Bartholin's cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Breast inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Coital bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Abnormal uterine bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Dyspareunia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Genital ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 2700 at risk

Adverse event: Nipple pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Penile blister
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Penile discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Polycystic ovaries
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Testicular pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 132 affected / 2700 at risk

Adverse event: Vulval ulceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 2700 at risk

Adverse event: Allergic sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 2700 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 2700 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 2700 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Tonsillar hypertrophy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 134 affected / 2700 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 2700 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 2700 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 2700 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 2700 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 2700 at risk

Adverse event: Hidradenitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Penile ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Pityriasis rosea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 2700 at risk

Adverse event: Pseudofolliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 2700 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 2700 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 2700 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 2700 at risk

Adverse event: Rash vesicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Skin depigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2700 at risk

Adverse event: Solar dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Urticaria papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 2700 at risk

Adverse event: Physical assault
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 2700 at risk

Adverse event: Victim of sexual abuse
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 2700 at risk

Adverse event: Any Event in SOC
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 2700 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2700 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 2700 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2700 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2700 at risk