Study: NCT02545101

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: INFECTION OF OPEN FRACTURES
Frequency: 1 affected / 100 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: HYPONATREMIA EPISODE
Frequency: 1 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: NATURAL DEATH (EXTREMELY OLD DEATH)
Frequency: 1 affected / 100 at risk

Adverse event: Blood sodium increased
Serious: yes
Organ System: Investigations
Notes: RAPID RAISE IN SODIUM LEVELS
Frequency: 1 affected / 100 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: NEUTROPENIA POST-CHEMOTHERAPY
Frequency: 1 affected / 100 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Fatal for 1 patient.
Frequency: 2 affected / 100 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Notes: EPILEPTIC SEIZURE
Frequency: 1 affected / 100 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: EXITUS BY SMALL CELL LUNG CANCER
Frequency: 1 affected / 100 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: OTITIS
Frequency: 1 affected / 100 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Cholangitis acute
Serious: no
Organ System: Hepatobiliary disorders
Notes: ACUTE COLANGITIS WITH FEVER AND ELEVATION OF LIVER ENZYMES
Frequency: 1 affected / 100 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 100 at risk

Adverse event: Blood sodium abnormal
Serious: no
Organ System: Investigations
Notes: NO IMPROVE SODIUM LEVELS
Frequency: 1 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 100 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk