Study: NCT02017444

Adverse event: IIH exacerbation
Serious: yes
Organ System: Eye disorders
Notes: IIH exacerbation requiring acute intervention
Frequency: 1 affected / 14 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Gastro-intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 14 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 14 at risk

Adverse event: Neoplasia
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 14 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 14 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 14 at risk

Adverse event: Immunological
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dermatological
Serious: no
Organ System: General disorders
Frequency: 5 affected / 14 at risk

Adverse event: Eyes, ear, nose, throat
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 14 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: tiredness; hot sweats; flu like symptoms; disrupted sleep; toothache/infection; breast pain; menstrual problems for more than 3 weeks; mouth ulcers; a cold; transient nausea and height headaches
Frequency: 5 affected / 14 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 17 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Gastro-intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 17 at risk

Adverse event: Genito-urinary
Serious: no
Organ System: General disorders
Frequency: 6 affected / 17 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 17 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 17 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 17 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 17 at risk

Adverse event: Dermatological
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Allergies
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Eyes, ear, nose, throat
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 12 affected / 17 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: tiredness; hot sweats; flu like symptoms; disrupted sleep; toothache/infection; breast pain; menstrual problems for more than 3 weeks; mouth ulcers; a cold; transient nausea and height headaches
Frequency: 7 affected / 17 at risk