Study: NCT02216071

Adverse event: Ear and labyrinth disorder
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ear discomfort, Ear pruritus, Otorrhoea, Ear Congestion, Ear haemorrhage, Ear swelling, Eustachian tube dysfunction, Excessive cerumen production, Hearing impaired, Tympanic membrane disorder, Tympanic membrane hyperaemia, Ear pain, External ear diso
Frequency: 18 affected / 247 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 247 at risk

Adverse event: General disorder and administration site conditions
Serious: no
Organ System: General disorders
Notes: Pyrexia, Facial pain, Pain
Frequency: 3 affected / 247 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Notes: Otitis externa, Otitis media, Sinusitis, Gastroenteritis viral, Candida infection, Conjuctivitis, Herpes zoster, Localised infection, Nasopharyngitis, Pharyngitis, Sepsis, Upper respiratory tract infection, Ear infection fungal, Fungal infection
Frequency: 13 affected / 247 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Arthropod bite, Hand fracture, Overdose, Concussion, Contusion Laceration, Lip Injurey, Skin abrasion
Frequency: 6 affected / 247 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthralgia, Temporomandibular joint syndrome, Back pain, Musculoskeletal pain
Frequency: 2 affected / 247 at risk

Adverse event: Nercous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, Dizziness, Hypoaesthesia, Presyncope, Sinus headache
Frequency: 5 affected / 247 at risk

Adverse event: Respiratory, thoracid and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, Dyspnoea, Epistaxis, Oropharyngeal pain, Rhinitis allergic, Rhinorrhoea
Frequency: 4 affected / 247 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, Dermatitis contact
Frequency: 1 affected / 247 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: A 41-year-old woman with a history of lupus, was hospitalized with lupus-associated Tempero Mandibular Joint TMJ syndrome with a lupus flare-up at 2 days after beginning study drug treatment. The SAE, which was deemed to be unrelated to study drug.
Frequency: 1 affected / 252 at risk

Adverse event: Ear and labyrinth disorder
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ear discomfort, Ear pruritus, Otorrhoea, Ear Congestion, Ear haemorrhage, Ear swelling, Eustachian tube dysfunction, Excessive cerumen production, Hearing impaired, Tympanic membrane disorder, Tympanic membrane hyperaemia, Ear pain, External ear diso
Frequency: 15 affected / 252 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 252 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 252 at risk

Adverse event: General disorder and administration site conditions
Serious: no
Organ System: General disorders
Notes: Pyrexia, Facial pain, Pain
Frequency: 1 affected / 252 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Notes: Otitis externa, Otitis media, Sinusitis, Gastroenteritis viral, Candida infection, Conjuctivitis, Herpes zoster, Localised infection, Nasopharyngitis, Pharyngitis, Sepsis, Upper respiratory tract infection, Ear infection fungal, Fungal infection
Frequency: 18 affected / 252 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Arthropod bite, Hand fracture, Overdose, Concussion, Contusion Laceration, Lip Injurey, Skin abrasion
Frequency: 3 affected / 252 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 252 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 252 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthralgia, Temporomandibular joint syndrome, Back pain, Musculoskeletal pain
Frequency: 2 affected / 252 at risk

Adverse event: Nercous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Headache, Dizziness, Hypoaesthesia, Presyncope, Sinus headache
Frequency: 5 affected / 252 at risk

Adverse event: Respiratory, thoracid and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough, Dyspnoea, Epistaxis, Oropharyngeal pain, Rhinitis allergic, Rhinorrhoea
Frequency: 3 affected / 252 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash, Dermatitis contact
Frequency: 4 affected / 252 at risk

Adverse event: Menarche
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 252 at risk