TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00413049

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 349 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 349 at risk

Adverse event: Jaw cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 349 at risk

Adverse event: Post herpetic neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 349 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 349 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 349 at risk
Study: NCT00413153

Adverse event: Giardiasis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: hospitalization required for Giardia lamblia infection
Frequency: 1 affected / 7 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: General disorders
Notes: Mental status changes requiring hospitalization, found to be caused by combination of prescribed opiates
Frequency: 1 affected / 7 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 7 at risk

Adverse event: Blood HIV RNA increased
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Gastrointestinal disorders
Notes: ALT and/or AST elevated to any degree above the upper limit of normal.
Frequency: 1 affected / 7 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk
Study: NCT00413374

Adverse event: Recurrent VTE
Serious: yes
Organ System: Cardiac disorders
Notes: The sole recurrent VTE in the once daily enoxaparin group was caused by heparin-induced thrombocytopenia with thrombosis in a patient who had been recently exposed to UFH.
Frequency: 1 affected / 40 at risk

Adverse event: Recurrent VTE
Serious: yes
Organ System: Cardiac disorders
Notes: The sole recurrent VTE in the once daily enoxaparin group was caused by heparin-induced thrombocytopenia with thrombosis in a patient who had been recently exposed to UFH.
Frequency: 3 affected / 80 at risk
Study: NCT00413400

Adverse event: Operative Surgical Procedure
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 placebo subject had surgery for cervical disc repair, and 1 etanercept subject had planned (elective) knee surgery
Frequency: 1 affected / 24 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Notes: Exacerbation of pre-existing schizophrenia requiring hospitalization
Frequency: 1 affected / 24 at risk

Adverse event: Bakers Cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dental Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Foot Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Operative Surgical Procedure
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 placebo subject had surgery for cervical disc repair, and 1 etanercept subject had planned (elective) knee surgery
Frequency: 1 affected / 16 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Notes: 1 subject receiving etanercept developed transient parasthesia in leg after giving study medication. Study drug was discontinued and symptoms resolved.
Frequency: 1 affected / 16 at risk

Adverse event: Bakers Cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Mild intermittent symptoms of tingling in hands and feet in a subject who had also experienced these symptoms prior to study participation
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 16 at risk
Study: NCT00413413

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 308 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 308 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 308 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 308 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 303 at risk
Study: NCT00413634

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT00414076

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4 at risk

Adverse event: Fever w/o neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mood Alteration (depression)
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 4 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain (joint)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain (muscle)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Pruritus/Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk
Study: NCT00414271

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: One patient developed a myocardial infarction after the first cycle of chemotherapy and was taken off protocol.
Frequency: 1 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 2 affected / 18 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 2 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 4 affected / 18 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 3 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 4 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 2 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 18 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 4 affected / 18 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 6 affected / 18 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 2 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade1
Frequency: 2 affected / 18 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 3 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 18 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 18 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 18 at risk
Study: NCT00414596

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Head Colds
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Sinus Headaches
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 20 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 20 at risk
Study: NCT00414635

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: melonoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: hospitalization status post cardiac catherization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: hospitalization status post gastric banding procedure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: nightsweats
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk
Study: NCT00414661

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 89 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 89 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk
Study: NCT00414765

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 7 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk
Study: NCT00414908

Adverse event: Hyperglycaemic conditions NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hyperglycaemic conditions NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Acute and Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Lower Limb Fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Thermal Burns
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Diabetes Mellitus (Incl Subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 51 at risk

Adverse event: Diabetic complication dermal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Parenchymal Lung Disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Upper respiratory Tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk
Study: NCT00415610

Adverse event: Neurological deterioration within 24 hours
Serious: no
Organ System: Nervous system disorders
Notes: defined as increase of 4 or more points on NIHSS or decrease of 2 or more points on GCS
Frequency: 1 affected / 18 at risk

Adverse event: Asymptomatic hematoma expansion
Serious: no
Organ System: Nervous system disorders
Notes: Hematoma expansion is defined as \> 33% increase in hematoma volume as measured by central reader between baseline and 24 hour head CT scans
Frequency: 6 affected / 18 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Symptomatic hematoma volume expansion
Serious: yes
Organ System: Nervous system disorders
Notes: defined as \> 33 % increase in hematoma volume as measured by central reader between baseline and 24 hour head CT scans, accompanied by neurological deterioration or new neurological symptoms
Frequency: 1 affected / 20 at risk

Adverse event: Neurological deterioration within 24 hours
Serious: no
Organ System: Nervous system disorders
Notes: defined as increase of 4 or more points on NIHSS or decrease of 2 or more points on GCS
Frequency: 2 affected / 20 at risk

Adverse event: Asymptomatic hematoma expansion
Serious: no
Organ System: Nervous system disorders
Notes: Hematoma expansion is defined as \> 33% increase in hematoma volume as measured by central reader between baseline and 24 hour head CT scans
Frequency: 2 affected / 20 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Acute respiratory distress syndrome (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hyperglycemia and hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Neurological deterioration within 24 hours
Serious: no
Organ System: Nervous system disorders
Notes: defined as increase of 4 or more points on NIHSS or decrease of 2 or more points on GCS
Frequency: 4 affected / 22 at risk

Adverse event: Asymptomatic hematoma expansion
Serious: no
Organ System: Nervous system disorders
Notes: Hematoma expansion is defined as \> 33% increase in hematoma volume as measured by central reader between baseline and 24 hour head CT scans
Frequency: 3 affected / 22 at risk
Study: NCT00415857

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT00415909

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Edema, Limb
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypopigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Musculoskeletal, Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Occular/Visual
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain, Extremity-Limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain, Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain, Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT00416078

Adverse event: fatal
Serious: yes
Organ System: Nervous system disorders
Notes: Participants were diagnosed with Alzheimer or other dementia
Frequency: 3 affected / 29 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: fatal
Serious: yes
Organ System: Nervous system disorders
Notes: Participants were diagnosed with Alzheimer or other dementia
Frequency: 4 affected / 24 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk
Study: NCT00416182

Adverse event: hospitalization for pulmonary exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: sinus surgery
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: hospitalization for pulmonary exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk