TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00310427

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 25 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Rash or pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Rash or pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk
Study: NCT00310765

Adverse event: headache and hyperactivity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk

Adverse event: dizziness and blurred vision
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: 60 yo woman did not disclose a history of alcohol abuse. She attempted suicide with an overdose of pregabalin. History available from emergency Psychiatrist. Patient was hospitalized and refused further follow up.
Frequency: 1 affected / 6 at risk

Adverse event: Night sweats
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: hand numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: gastroenteritis and dizziness
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk
Study: NCT00311155

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 694 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 694 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 694 at risk

Adverse event: Myocardial infacrtion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 694 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 694 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 694 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 694 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 694 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 694 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 694 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 694 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 77 affected / 694 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 694 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 694 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 694 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 694 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 32 affected / 694 at risk
Study: NCT00311168

Adverse event: LEAD DISLODGEMENT OR MIGRATION
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 134 at risk

Adverse event: DIMINISHING R-WAVE AMPLITUDE
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 134 at risk
Study: NCT00311363

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 326 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 326 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 326 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 326 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 326 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 326 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 98 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 98 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 98 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 96 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 96 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 96 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 96 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk
Study: NCT00311623

Adverse event: Post-operative ileus
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Post-operative ileus
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 20 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1-2 Neutropenia without fever
Frequency: 2 affected / 20 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 thrombocytopenia
Frequency: 1 affected / 20 at risk

Adverse event: Severe thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2 at risk
Study: NCT00311766

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: Cellulitis was resolved in 27 days
Frequency: 1 affected / 22 at risk
Study: NCT00312338

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 105 at risk
Study: NCT00312884

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: All cause hospitalisation
Frequency: 23 affected / 91 at risk

Adverse event: Heart Failure Admission
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 91 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: All cause hospitalisation
Frequency: 33 affected / 91 at risk

Adverse event: Heart Failure Admission
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 91 at risk
Study: NCT00312897

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT00313443

Adverse event: Local Complications (if Any) Caused by Fat Tissue Needle Aspirations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk
Study: NCT00313560

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Intractable nausea/vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Elevated AST/elevated ALT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 48 at risk

Adverse event: Elevated ALP
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 48 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 48 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 48 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 31 affected / 48 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 30 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 48 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 29 affected / 48 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 48 at risk
Study: NCT00314808

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 33 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 33 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 33 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 33 at risk

Adverse event: Reproductive system and breast disorders - Other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 33 at risk
Study: NCT00315055

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 153 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 153 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 30 affected / 153 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 21 affected / 153 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 83 affected / 153 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 41 affected / 152 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 153 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 153 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 54 affected / 153 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 152 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 152 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 152 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 58 affected / 152 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 152 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 16 affected / 152 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 74 affected / 152 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 152 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 152 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 152 at risk

Adverse event: Crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 152 at risk
Study: NCT00315120

Adverse event: Any serious adverse event according to Food and Drug Administration definition
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Any other adverse event
Serious: no
Organ System: General disorders
Frequency: 6 affected / 115 at risk

Adverse event: Any serious adverse event according to Food and Drug Administration definition
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 115 at risk

Adverse event: Any other adverse event
Serious: no
Organ System: General disorders
Frequency: 5 affected / 118 at risk

Adverse event: Any serious adverse event according to Food and Drug Administration definition
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 115 at risk

Adverse event: Any other adverse event
Serious: no
Organ System: General disorders
Frequency: 4 affected / 115 at risk

Adverse event: Any serious adverse event according to Food and Drug Administration definition
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Any other adverse event
Serious: no
Organ System: General disorders
Frequency: 3 affected / 107 at risk
Study: NCT00315146

Adverse event: Hospitalization for DVT
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hospitalization for brain tumor
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

Adverse event: Fainted during muscle biopsy procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 22 at risk
Study: NCT00315302

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 90 at risk

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 26 at risk

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 34 at risk
Study: NCT00315328

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 95 at risk

Adverse event: Light sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: Systemic
Serious: no
Organ System: General disorders
Notes: Systemic side effects were reported by 2 subjects using atropine - 1 reported irritability, and another reported urinary urgency, dry mouth, and excessive thirst.
Frequency: 2 affected / 22 at risk
Study: NCT00315822

Adverse event: All-cause mortality
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 198 at risk

Adverse event: All-cause mortality
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 202 at risk
Study: NCT00316004

Adverse event: Hypernatremia (sodium>160 mEq/L) requiring intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hypernatremia (sodium\>160 mEq/L) requiring intervention to decrease serum sodium level to prevent additional complications.
Frequency: 10 affected / 349 at risk

Adverse event: Increased intracranial hemorrhage on serial head CT
Serious: yes
Organ System: Nervous system disorders
Notes: Increased intracranial hemorrhage on serial head CT was observed.
Frequency: 57 affected / 349 at risk

Adverse event: Seizures in the first 24 hours
Serious: yes
Organ System: Nervous system disorders
Notes: Incidents of seizures observed in the first 24 hours
Frequency: 4 affected / 359 at risk

Adverse event: Hypernatremia (sodium>160 mEq/L) requiring intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hypernatremia (sodium\>160 mEq/L) requiring intervention to decrease serum sodium level to prevent additional complications.
Frequency: 14 affected / 334 at risk

Adverse event: Increased intracranial hemorrhage on serial head CT
Serious: yes
Organ System: Nervous system disorders
Notes: Increased intracranial hemorrhage on serial head CT was observed.
Frequency: 60 affected / 325 at risk

Adverse event: Seizures in the first 24 hours
Serious: yes
Organ System: Nervous system disorders
Notes: Incidents of seizures observed in the first 24 hours
Frequency: 3 affected / 341 at risk

Adverse event: Hypernatremia (sodium>160 mEq/L) requiring intervention
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hypernatremia (sodium\>160 mEq/L) requiring intervention to decrease serum sodium level to prevent additional complications.
Frequency: 13 affected / 573 at risk

Adverse event: Increased intracranial hemorrhage on serial head CT
Serious: yes
Organ System: Nervous system disorders
Notes: Increased intracranial hemorrhage on serial head CT was observed.
Frequency: 122 affected / 560 at risk

Adverse event: Seizures in the first 24 hours
Serious: yes
Organ System: Nervous system disorders
Notes: Incidents of seizures observed in the first 24 hours
Frequency: 12 affected / 582 at risk