Study: NCT01003639

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Elevated lipase with pancreatititis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Allergic reaction of unknown origin
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Live birth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 86 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 86 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 86 at risk

Adverse event: Decreased CO2
Serious: no
Organ System: General disorders
Frequency: 9 affected / 86 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 86 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 86 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 86 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 86 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 86 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 86 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 86 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 86 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 26 affected / 86 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 86 at risk

Adverse event: Post-LP syndrome
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 86 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 86 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 86 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 11 affected / 86 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 12 affected / 86 at risk

Adverse event: Rapidly failing vision
Serious: yes
Organ System: Eye disorders
Notes: Rapidly failing vision requiring hospitalization and treatment with optic nerve sheath fenestration
Frequency: 2 affected / 79 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 79 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 79 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 79 at risk

Adverse event: Pulmnary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Ventriculo-peritoneal shunt
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 79 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 79 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 79 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 79 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 79 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 8 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 79 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 79 at risk

Adverse event: Post-LP syndrome
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 79 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 79 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 79 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 79 at risk