Study: NCT00865566

Adverse event: Any event in SOC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Ischaemic coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Colitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Acute and chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Pain and discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Withdrawal and rebound effects
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Allergies to foods, food additives, drugs and other chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 1253 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1253 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1253 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1253 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1253 at risk

Adverse event: Upper respiratory tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Clostridia infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1253 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Skin structures and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Staphylococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1253 at risk

Adverse event: Streptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Bone and joint infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Borrelial infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Herpes viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Infectious disorders carrier
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Urinary tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 1253 at risk

Adverse event: Limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1253 at risk

Adverse event: Skull fractures, facial bone fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1253 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1253 at risk

Adverse event: Overdoses NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Poisoning and toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1253 at risk

Adverse event: Skin injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Cardiovascular injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Cerebral injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Thermal burns
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1253 at risk

Adverse event: Metabolism tests NEC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Potassium imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Muscle weakness conditions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1253 at risk

Adverse event: Prostatic neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1253 at risk

Adverse event: Colorectal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1253 at risk

Adverse event: Leukaemias acute lymphocytic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1253 at risk

Adverse event: Thyroid neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Mononeuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Optic nerve disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Transient cerebrovascular events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 23 affected / 1253 at risk

Adverse event: Suicidal and self-injurious behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 1253 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Substance related and addictive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Anxiety symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Confusion and disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Mental disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Schizoaffective and schizophreniform disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Somatic symptom disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Renal failure and impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Testicular and epididymal disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Skin and subcutaneous tissue ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Vascular hypotensive disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 1253 at risk

Adverse event: Lymphatic system disorders NEC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 1253 at risk

Adverse event: Anaemias NEC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Spleen disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Supraventricular arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Male reproductive tract disorders congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 1253 at risk

Adverse event: Ear disorders NEC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Inner ear signs and symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1253 at risk

Adverse event: External ear disorders NEC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Middle ear disorders NEC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Eustachian tube disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Tympanic membrane disorders (excl infections)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Thyroid hypofunction disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Endocrine abnormalities of gonadal function NEC
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Male gonadal function disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Thyroid hyperfunction disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 1253 at risk

Adverse event: Lid, lash and lacrimal infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Ocular disorders NEC
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Conjunctival and corneal bleeding and vascular disorders
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Visual disorders NEC
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Conjunctival infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Eyelid movement disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Lacrimation disorders
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Ocular infections, inflammations and associated manifestations
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Glaucomas (excl congenital)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Refractive and accommodative disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 149 affected / 1253 at risk

Adverse event: Diarrhoea (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 1253 at risk

Adverse event: Nausea and vomiting symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 1253 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 1253 at risk

Adverse event: Stomatitis and ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1253 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Haemorrhoids and gastrointestinal varices (excl oesophageal)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Anal and rectal disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Gastrointestinal signs and symptoms NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Gastrointestinal disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Dental pain and sensation disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Dyspeptic signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Intestinal haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Gastritis (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Abdominal hernias NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Anal and rectal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Dental and periodontal infections and inflammations
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Diaphragmatic hernias
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Flatulence, bloating and distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Gingival disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Gingival haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Oesophageal ulcers and perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Tongue disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Tongue signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Gastrointestinal inflammatory disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Oral dryness and saliva altered
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Dental disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Peptic ulcers and perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: General disorders
Frequency: 138 affected / 1253 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Frequency: 65 affected / 1253 at risk

Adverse event: Asthenic conditions
Serious: no
Organ System: General disorders
Frequency: 41 affected / 1253 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 17 affected / 1253 at risk

Adverse event: Feelings and sensations NEC
Serious: no
Organ System: General disorders
Frequency: 10 affected / 1253 at risk

Adverse event: General signs and symptoms NEC
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Pain and discomfort NEC
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Administration site reactions NEC
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Therapeutic and nontherapeutic responses
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Vaccination site reactions
Serious: no
Organ System: General disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Withdrawal and rebound effects
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Inflammations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Hepatocellular damage and hepatitis NEC
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Hepatobiliary signs and symptoms
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Immune system disorders
Frequency: 25 affected / 1253 at risk

Adverse event: Atopic disorders
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 1253 at risk

Adverse event: Allergies to foods, food additives, drugs and other chemicals
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 1253 at risk

Adverse event: Allergic conditions NEC
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Infections and infestations
Frequency: 531 affected / 1253 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 275 affected / 1253 at risk

Adverse event: Neisseria infections
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 1253 at risk

Adverse event: Viral infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 1253 at risk

Adverse event: Chlamydial infections
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 1253 at risk

Adverse event: Treponema infections
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 1253 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 1253 at risk

Adverse event: Herpes viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 1253 at risk

Adverse event: Streptococcal infections
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 1253 at risk

Adverse event: Urinary tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 1253 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 1253 at risk

Adverse event: Papilloma viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 1253 at risk

Adverse event: Bacterial infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 1253 at risk

Adverse event: Eye and eyelid infections
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 1253 at risk

Adverse event: Skin structures and soft tissue infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 1253 at risk

Adverse event: Dental and oral soft tissue infections
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 1253 at risk

Adverse event: Ectoparasitic infestations
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1253 at risk

Adverse event: Ear infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1253 at risk

Adverse event: Staphylococcal infections
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 1253 at risk

Adverse event: Tinea infections
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 1253 at risk

Adverse event: Influenza viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1253 at risk

Adverse event: Infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1253 at risk

Adverse event: Male reproductive tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1253 at risk

Adverse event: Fungal infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1253 at risk

Adverse event: Hepatitis viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Candida infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Molluscum contagiosum viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Epstein-Barr viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Giardia infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Amoebic infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Caliciviral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Coxsackie viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Cytomegaloviral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Helicobacter infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 108 affected / 1253 at risk

Adverse event: Skin injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 1253 at risk

Adverse event: Muscle, tendon and ligament injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 1253 at risk

Adverse event: Non-site specific injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 1253 at risk

Adverse event: Non-site specific procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1253 at risk

Adverse event: Limb fractures and dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1253 at risk

Adverse event: Site specific injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1253 at risk

Adverse event: Neurological and psychiatric procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1253 at risk

Adverse event: Bone and joint injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1253 at risk

Adverse event: Thermal burns
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1253 at risk

Adverse event: Exposures to agents or circumstances NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1253 at risk

Adverse event: Radiation injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1253 at risk

Adverse event: Cerebral injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1253 at risk

Adverse event: Fractures and dislocations NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Eye injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1253 at risk

Adverse event: Thoracic cage fractures and dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Chest and lung injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1253 at risk

Adverse event: Overdoses NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Poisoning and toxicity
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Vaccination related complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Investigations
Frequency: 39 affected / 1253 at risk

Adverse event: Vascular tests NEC (incl blood pressure)
Serious: no
Organ System: Investigations
Frequency: 28 affected / 1253 at risk

Adverse event: Reproductive hormone analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 1253 at risk

Adverse event: Liver function analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 1253 at risk

Adverse event: Red blood cell analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1253 at risk

Adverse event: Carbohydrate tolerance analyses (incl diabetes)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1253 at risk

Adverse event: Digestive enzymes
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1253 at risk

Adverse event: Mineral and electrolyte analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1253 at risk

Adverse event: Cardiac auscultatory investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1253 at risk

Adverse event: Coagulation and bleeding analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1253 at risk

Adverse event: Heart rate and pulse investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1253 at risk

Adverse event: Musculoskeletal and soft tissue tests NEC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1253 at risk

Adverse event: Tissue enzyme analyses NEC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 1253 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Fat soluble vitamin deficiencies and disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Appetite disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Elevated cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Disorders of purine metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1253 at risk

Adverse event: General nutritional disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Potassium imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Fluid intake increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Food malabsorption and intolerance syndromes (excl sugar intolerance)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Lipid metabolism and deposit disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Water soluble vitamin deficiencies
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Protein metabolism disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 97 affected / 1253 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 1253 at risk

Adverse event: Muscle pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 1253 at risk

Adverse event: Joint related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 1253 at risk

Adverse event: Muscle related signs and symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Tendon disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Bone related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Arthropathies NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Bone disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Bursal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Intervertebral disc disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Cartilage disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Extremity deformities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Joint related disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Rheumatoid arthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Synovial disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 18 affected / 1253 at risk

Adverse event: Skin neoplasms benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 1253 at risk

Adverse event: Lip and oral cavity neoplasms benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1253 at risk

Adverse event: Skin neoplasms malignant and unspecified (excl melanoma)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1253 at risk

Adverse event: Soft tissue neoplasms benign NEC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Nervous system disorders
Frequency: 103 affected / 1253 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 1253 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 1253 at risk

Adverse event: Paraesthesias and dysaesthesias
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 1253 at risk

Adverse event: Migraine headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Sensory abnormalities NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Disturbances in consciousness NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Mononeuropathies
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Peripheral neuropathies NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Lumbar spinal cord and nerve root disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Narcolepsy and hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Memory loss (excl dementia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Neurologic visual problems NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Sleep disturbances NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Psychiatric disorders
Frequency: 72 affected / 1253 at risk

Adverse event: Depressive disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 1253 at risk

Adverse event: Anxiety symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 1253 at risk

Adverse event: Disturbances in initiating and maintaining sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 1253 at risk

Adverse event: Substance related and addictive disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 1253 at risk

Adverse event: Attention deficit and disruptive behaviour disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Anxiety disorders NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Bipolar disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Panic attacks and disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Sexual desire disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Stress disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Schizophrenia NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Fluctuating mood symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Mental disorders NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Mood alterations with depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Schizoaffective and schizophreniform disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Somatic symptom disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 1253 at risk

Adverse event: Bladder and urethral symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 1253 at risk

Adverse event: Renal lithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1253 at risk

Adverse event: Urethral disorders NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Urinary abnormalities
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Urinary tract signs and symptoms NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Bladder neoplasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 27 affected / 1253 at risk

Adverse event: Penile disorders NEC (excl erection and ejaculation)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 12 affected / 1253 at risk

Adverse event: Reproductive tract signs and symptoms NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Erection and ejaculation conditions and disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Prostate and seminal vesicles infections and inflammations
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Reproductive tract disorders NEC (excl neoplasms)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Testicular and epididymal disorders NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Breast disorders NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Sexual function and fertility disorders NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Spermatogenesis and semen disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 123 affected / 1253 at risk

Adverse event: Upper respiratory tract signs and symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 49 affected / 1253 at risk

Adverse event: Coughing and associated symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 1253 at risk

Adverse event: Nasal congestion and inflammations
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 1253 at risk

Adverse event: Paranasal sinus disorders (excl infections and neoplasms)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 1253 at risk

Adverse event: Bronchospasm and obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Pharyngeal disorders (excl infections and neoplasms)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Breathing abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Nasal disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Respiratory tract disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Pulmonary oedemas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Respiratory failures (excl neonatal)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 112 affected / 1253 at risk

Adverse event: Dermatitis and eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 1253 at risk

Adverse event: Rashes, eruptions and exanthems NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 1253 at risk

Adverse event: Apocrine and eccrine gland disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 1253 at risk

Adverse event: Dermal and epidermal conditions NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 1253 at risk

Adverse event: Pruritus NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 1253 at risk

Adverse event: Erythemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 1253 at risk

Adverse event: Psoriatic conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1253 at risk

Adverse event: Acnes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1253 at risk

Adverse event: Angioedemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Bullous conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Papulosquamous conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Pilar disorders NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Purpura and related conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Skin and subcutaneous tissue ulcerations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Skin cysts and polyps
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Skin preneoplastic conditions NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Alopecias
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Hyperkeratoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Vascular disorders
Frequency: 33 affected / 1253 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 1253 at risk

Adverse event: Peripheral vascular disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1253 at risk

Adverse event: Haemorrhages NEC
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1253 at risk

Adverse event: Lymphoedemas
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1253 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1251 at risk

Adverse event: Ischaemic coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Coronary artery disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Heart failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Ventricular arrhythmias and cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Haemoglobinopathies congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 1251 at risk

Adverse event: Colitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Acute and chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Duodenal ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Intestinal ulcers and perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Abdominal hernias NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Gastric ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Gastrointestinal disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Gastrointestinal stenosis and obstruction NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Oesophageal ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Rectal inflammations NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Pain and discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Death and sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Acute and chronic sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 1251 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1251 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1251 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1251 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Upper respiratory tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1251 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Skin structures and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Streptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Breast infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Viral infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 1251 at risk

Adverse event: Limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Skull fractures, facial bone fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1251 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Overdoses NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Poisoning and toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Skin injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Spinal fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Abdominal injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Cardiac and vascular procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Muscle, tendon and ligament injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Pathways and sources of exposure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1251 at risk

Adverse event: Liver function analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Bursal disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Intervertebral disc disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1251 at risk

Adverse event: Prostatic neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1251 at risk

Adverse event: Gastric neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1251 at risk

Adverse event: Testicular neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Encephalopathies NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1251 at risk

Adverse event: Device malfunction events NEC
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 22 affected / 1251 at risk

Adverse event: Suicidal and self-injurious behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 1251 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Substance related and addictive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Bipolar disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Anxiety symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Psychotic disorder NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Schizophrenia NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Renal lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Non-site specific necrosis and vascular insufficiency NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 1251 at risk

Adverse event: Lymphatic system disorders NEC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 1251 at risk

Adverse event: Leukocytoses NEC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Red blood cell abnormal findings NEC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Supraventricular arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Cardiac signs and symptoms NEC
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Male reproductive tract disorders congenital
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 1251 at risk

Adverse event: Ear disorders NEC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Inner ear signs and symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1251 at risk

Adverse event: External ear disorders NEC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Hearing losses
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Thyroid hypofunction disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 1251 at risk

Adverse event: Lid, lash and lacrimal infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Ocular disorders NEC
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Conjunctival and corneal bleeding and vascular disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Ocular sensation disorders
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Conjunctival infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Eyelid movement disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Ocular infections, inflammations and associated manifestations
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Blindness (excl colour blindness)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Retinal, choroid and vitreous infections and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 146 affected / 1251 at risk

Adverse event: Diarrhoea (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 1251 at risk

Adverse event: Nausea and vomiting symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 1251 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 1251 at risk

Adverse event: Stomatitis and ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1251 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1251 at risk

Adverse event: Haemorrhoids and gastrointestinal varices (excl oesophageal)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1251 at risk

Adverse event: Anal and rectal disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1251 at risk

Adverse event: Gastrointestinal signs and symptoms NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1251 at risk

Adverse event: Gastrointestinal disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Dental pain and sensation disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Dyspeptic signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1251 at risk

Adverse event: Intestinal haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Gastritis (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Colitis (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Abdominal hernias NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Anal and rectal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Dental and periodontal infections and inflammations
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Diaphragmatic hernias
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Flatulence, bloating and distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Gingival disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Gingival haemorrhages
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Oesophageal ulcers and perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Tongue signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Benign neoplasms gastrointestinal (excl oral cavity)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Oral dryness and saliva altered
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Abdominal findings abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Anal and rectal pains
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Faecal abnormalities NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Gastrointestinal dyskinetic disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Gastrointestinal fistulae
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Inguinal hernias
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Oral soft tissue pain and paraesthesia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Rectal inflammations NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: General disorders
Frequency: 104 affected / 1251 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Frequency: 33 affected / 1251 at risk

Adverse event: Asthenic conditions
Serious: no
Organ System: General disorders
Frequency: 27 affected / 1251 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 15 affected / 1251 at risk

Adverse event: Feelings and sensations NEC
Serious: no
Organ System: General disorders
Frequency: 9 affected / 1251 at risk

Adverse event: General signs and symptoms NEC
Serious: no
Organ System: General disorders
Frequency: 10 affected / 1251 at risk

Adverse event: Pain and discomfort NEC
Serious: no
Organ System: General disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Administration site reactions NEC
Serious: no
Organ System: General disorders
Frequency: 6 affected / 1251 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Therapeutic and nontherapeutic responses
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Vaccination site reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Mass conditions NEC
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Withdrawal and rebound effects
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Hepatocellular damage and hepatitis NEC
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Cholestasis and jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Immune system disorders
Frequency: 14 affected / 1251 at risk

Adverse event: Atopic disorders
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 1251 at risk

Adverse event: Allergies to foods, food additives, drugs and other chemicals
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Allergic conditions NEC
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Anaphylactic and anaphylactoid responses
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Infections and infestations
Frequency: 549 affected / 1251 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 254 affected / 1251 at risk

Adverse event: Neisseria infections
Serious: no
Organ System: Infections and infestations
Frequency: 83 affected / 1251 at risk

Adverse event: Viral infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 1251 at risk

Adverse event: Chlamydial infections
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 1251 at risk

Adverse event: Treponema infections
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 1251 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 1251 at risk

Adverse event: Herpes viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 1251 at risk

Adverse event: Streptococcal infections
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 1251 at risk

Adverse event: Urinary tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 1251 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 1251 at risk

Adverse event: Papilloma viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 1251 at risk

Adverse event: Bacterial infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 1251 at risk

Adverse event: Eye and eyelid infections
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 1251 at risk

Adverse event: Skin structures and soft tissue infections
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 1251 at risk

Adverse event: Dental and oral soft tissue infections
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 1251 at risk

Adverse event: Ectoparasitic infestations
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 1251 at risk

Adverse event: Ear infections
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 1251 at risk

Adverse event: Staphylococcal infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1251 at risk

Adverse event: Tinea infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1251 at risk

Adverse event: Influenza viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1251 at risk

Adverse event: Infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1251 at risk

Adverse event: Male reproductive tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1251 at risk

Adverse event: Fungal infections NEC
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Hepatitis viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1251 at risk

Adverse event: Candida infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1251 at risk

Adverse event: Molluscum contagiosum viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1251 at risk

Adverse event: Epstein-Barr viral infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Giardia infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Tuberculous infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1251 at risk

Adverse event: Bone and joint infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Clostridia infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Escherichia infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Haemophilus infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Nematode infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 101 affected / 1251 at risk

Adverse event: Skin injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 1251 at risk

Adverse event: Muscle, tendon and ligament injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 1251 at risk

Adverse event: Non-site specific injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1251 at risk

Adverse event: Non-site specific procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1251 at risk

Adverse event: Limb fractures and dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 1251 at risk

Adverse event: Site specific injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 1251 at risk

Adverse event: Neurological and psychiatric procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1251 at risk

Adverse event: Bone and joint injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1251 at risk

Adverse event: Thermal burns
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1251 at risk

Adverse event: Exposures to agents or circumstances NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Radiation injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1251 at risk

Adverse event: Cerebral injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Fractures and dislocations NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1251 at risk

Adverse event: Eye injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Skull fractures, facial bone fractures and dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1251 at risk

Adverse event: Thoracic cage fractures and dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Gastrointestinal and hepatobiliary procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1251 at risk

Adverse event: Ear injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Reproductive system and breast injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Spinal fractures and dislocations
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Investigations
Frequency: 63 affected / 1251 at risk

Adverse event: Vascular tests NEC (incl blood pressure)
Serious: no
Organ System: Investigations
Frequency: 47 affected / 1251 at risk

Adverse event: Reproductive hormone analyses
Serious: no
Organ System: Investigations
Frequency: 7 affected / 1251 at risk

Adverse event: Liver function analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 1251 at risk

Adverse event: Red blood cell analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1251 at risk

Adverse event: Carbohydrate tolerance analyses (incl diabetes)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1251 at risk

Adverse event: Platelet analyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1251 at risk

Adverse event: Bacteria identification and serology (excl mycobacteria)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1251 at risk

Adverse event: Investigations NEC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1251 at risk

Adverse event: Mycobacteria identification and serology
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1251 at risk

Adverse event: White blood cell analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 1251 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Fat soluble vitamin deficiencies and disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Appetite disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Elevated cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1251 at risk

Adverse event: General nutritional disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Potassium imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Food malabsorption and intolerance syndromes (excl sugar intolerance)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Water soluble vitamin deficiencies
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Elevated triglycerides
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Hyperlipidaemias NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Hypoglycaemic conditions NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Magnesium metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Sugar intolerance (excl glucose intolerance)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Total fluid volume decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 107 affected / 1251 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 1251 at risk

Adverse event: Muscle pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 1251 at risk

Adverse event: Joint related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 1251 at risk

Adverse event: Muscle related signs and symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Tendon disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Bone related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Arthropathies NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Bone disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Bursal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Intervertebral disc disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Muscle weakness conditions
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Muscle tone abnormalities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Musculoskeletal and connective tissue infections and inflammations NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Osteoarthropathies
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Soft tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 17 affected / 1251 at risk

Adverse event: Skin neoplasms benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 1251 at risk

Adverse event: Lip and oral cavity neoplasms benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1251 at risk

Adverse event: Nervous system neoplasms benign NEC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1251 at risk

Adverse event: Reproductive neoplasms male benign NEC
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 1251 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 1251 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 1251 at risk

Adverse event: Paraesthesias and dysaesthesias
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 1251 at risk

Adverse event: Migraine headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Sensory abnormalities NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Disturbances in consciousness NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Mononeuropathies
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Peripheral neuropathies NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Lumbar spinal cord and nerve root disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Narcolepsy and hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Cervical spinal cord and nerve root disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Coordination and balance disturbances
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Disturbances in sleep phase rhythm
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Facial cranial nerve disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Mental impairment (excl dementia and memory loss)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Psychiatric disorders
Frequency: 65 affected / 1251 at risk

Adverse event: Depressive disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 1251 at risk

Adverse event: Anxiety symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 1251 at risk

Adverse event: Disturbances in initiating and maintaining sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 1251 at risk

Adverse event: Substance related and addictive disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Attention deficit and disruptive behaviour disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Anxiety disorders NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Bipolar disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Panic attacks and disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Sexual desire disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Stress disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Emotional and mood disturbances NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Behaviour and socialisation disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Fear symptoms and phobic disorders (incl social phobia)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Mood disorders NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Sleep disorders NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Suicidal and self-injurious behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 1251 at risk

Adverse event: Bladder and urethral symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 1251 at risk

Adverse event: Renal lithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 1251 at risk

Adverse event: Urethral disorders NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Urinary abnormalities
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Urinary tract signs and symptoms NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 26 affected / 1251 at risk

Adverse event: Penile disorders NEC (excl erection and ejaculation)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 1251 at risk

Adverse event: Reproductive tract signs and symptoms NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Erection and ejaculation conditions and disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 1251 at risk

Adverse event: Prostate and seminal vesicles infections and inflammations
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Reproductive tract disorders NEC (excl neoplasms)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Testicular and epididymal disorders NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Breast signs and symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Scrotal disorders NEC
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Pelvic prolapse conditions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Testicular and epididymal neoplasms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 1251 at risk

Adverse event: Upper respiratory tract signs and symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 44 affected / 1251 at risk

Adverse event: Coughing and associated symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 1251 at risk

Adverse event: Nasal congestion and inflammations
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 1251 at risk

Adverse event: Paranasal sinus disorders (excl infections and neoplasms)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1251 at risk

Adverse event: Bronchospasm and obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1251 at risk

Adverse event: Pharyngeal disorders (excl infections and neoplasms)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Breathing abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Nasal disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Respiratory tract disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 86 affected / 1251 at risk

Adverse event: Dermatitis and eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 1251 at risk

Adverse event: Rashes, eruptions and exanthems NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 1251 at risk

Adverse event: Apocrine and eccrine gland disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 1251 at risk

Adverse event: Dermal and epidermal conditions NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 1251 at risk

Adverse event: Pruritus NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 1251 at risk

Adverse event: Erythemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Psoriatic conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Acnes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1251 at risk

Adverse event: Angioedemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Bullous conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Papulosquamous conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Pilar disorders NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Purpura and related conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Skin cysts and polyps
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Dermatitis ascribed to specific agent
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Hyperpigmentation disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Photosensitivity and photodermatosis conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Rosaceas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 1251 at risk

Adverse event: Crime victims
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 1251 at risk

Adverse event: Any event in SOC
Serious: no
Organ System: Vascular disorders
Frequency: 49 affected / 1251 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 42 affected / 1251 at risk

Adverse event: Peripheral vascular disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1251 at risk

Adverse event: Haemorrhages NEC
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1251 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1251 at risk