TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00356200

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: cold/sinus symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

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

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

Adverse event: Injection site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: local reaction, occurred in both fluphenazine treated and placebo treated lesions
Frequency: 1 affected / 5 at risk

Adverse event: itchy lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: local reaction. In both cohort 1 patients, occurred in both fluphenazine treated and placebo treated lesions.

In the cohort 2 patient, occurred in only fluphenazine treated lesion.
Frequency: 2 affected / 5 at risk

Adverse event: lesion pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: local reaction, occurred in only fluphenazine treated lesion
Frequency: 1 affected / 5 at risk

Adverse event: psoriatic lesion spreading
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: local reaction, occurred in both fluphenazine treated and placebo treated lesions in addition to other non target lesions.
Frequency: 1 affected / 5 at risk

Adverse event: cold/sinus symptoms
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: contact lens irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: itchy lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: local reaction. In both cohort 1 patients, occurred in both fluphenazine treated and placebo treated lesions.

In the cohort 2 patient, occurred in only fluphenazine treated lesion.
Frequency: 1 affected / 5 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: sunburn (1st degree)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: local reaction
Frequency: 1 affected / 5 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk
Study: NCT00356369

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 374 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 374 at risk

Adverse event: Any Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 143 affected / 370 at risk

Adverse event: Any Redness
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 57 affected / 370 at risk

Adverse event: Any Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 42 affected / 370 at risk

Adverse event: Any Fatigue
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 55 affected / 371 at risk

Adverse event: Any Headache
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 65 affected / 371 at risk

Adverse event: Any Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 40 affected / 124 at risk

Adverse event: Any Redness
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 8 affected / 124 at risk

Adverse event: Any Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 4 affected / 124 at risk

Adverse event: Any Fatigue
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 13 affected / 125 at risk

Adverse event: Any Headache
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 15 affected / 125 at risk
Study: NCT00356759

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Fatal respiratory failure
Frequency: 1 affected / 124 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Melena
Frequency: 2 affected / 124 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bleeding from the nose that did not fulfill criteria for major bleeding
Frequency: 4 affected / 124 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary tract bleeding that did not meet criteria for major bleeding
Frequency: 2 affected / 124 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Bleeding from rectum bleeding that did not meet criteria for major bleeding
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 126 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: Pancreatitis with fatal septic shock
Frequency: 1 affected / 126 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Fatal respiratory failure
Frequency: 1 affected / 126 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Melena
Frequency: 1 affected / 126 at risk

Adverse event: Renal infarct
Serious: yes
Organ System: Renal and urinary disorders
Notes: Arterial embolism
Frequency: 1 affected / 126 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bleeding from the nose that did not fulfill criteria for major bleeding
Frequency: 1 affected / 126 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary tract bleeding that did not meet criteria for major bleeding
Frequency: 1 affected / 126 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Bleeding from rectum bleeding that did not meet criteria for major bleeding
Frequency: 1 affected / 126 at risk

Adverse event: Subconjunctival bleeding
Serious: no
Organ System: Eye disorders
Notes: Subconjunctival eye bleeding that did not meet criteria for major bleeding
Frequency: 1 affected / 126 at risk
Study: NCT00356863

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Total mortality
Frequency: 16 affected / 504 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 61 affected / 504 at risk

Adverse event: acute, but ill-defined cerebrovascular disease (apoplexy, n.o.s)/transient cerebral ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 31 affected / 504 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 504 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Total mortality
Frequency: 32 affected / 523 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 84 affected / 523 at risk

Adverse event: acute, but ill-defined cerebrovascular disease (apoplexy, n.o.s)/transient cerebral ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 35 affected / 523 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 523 at risk
Study: NCT00357097

Adverse event: Back pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 197 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 197 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 197 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 197 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 197 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 197 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 197 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 197 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 67 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 67 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 67 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 67 at risk
Study: NCT00357214

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 42 at risk

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 43 at risk
Study: NCT00357331

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 42 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 42 at risk

Adverse event: Traumatic Ankle Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 41 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 41 at risk
Study: NCT00357955

Adverse event: Lower Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: seen in the emergency room on 7/25/05 for lower back pain
Frequency: 1 affected / 58 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Notes: seen in the emergency room and admitted on 7/14/05 for syncope
Frequency: 1 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: seen in the emergence room for cough
Frequency: 1 affected / 58 at risk

Adverse event: Cellulitis Abcess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: was seen in the emergency room on 9/14/05 for cellulitis, hypertension and skin abscess.
Frequency: 1 affected / 58 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: was seen in the emergency room on 10/2/05 for a laceration
Frequency: 1 affected / 58 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: was seen in the emergency room on 8/19/05 for blepheritis
Frequency: 1 affected / 58 at risk

Adverse event: Toe infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: was seen in the emergency room on 11/17/05 for a toe infection
Frequency: 1 affected / 58 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: was seen in the emergency room on 1/2/06 for an ear and headache
Frequency: 1 affected / 58 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: was seen in the emergency room, on 11/19/05 for acute bronchitis
Frequency: 1 affected / 58 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: was seen in the emergency room on 12/1/05 for hypertension
Frequency: 1 affected / 58 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: was seen in the emergency room on 2/1/06 for hematuria and abdominal pain
Frequency: 1 affected / 58 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: was seen in the emergency room on 2/7/06 for rash
Frequency: 1 affected / 58 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: was admitted into the hospital for abnormal nonspecific EKG findings from 1/25/06 until 2/1/06
Frequency: 1 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: seen in the emergence room for cough
Frequency: 1 affected / 51 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: was seen in the emergency room on 5/29/07 for hypoglycemia
Frequency: 1 affected / 51 at risk
Study: NCT00358007

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

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

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk
Study: NCT00358462

Adverse event: Unstable mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 304 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 304 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 6 affected / 304 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: flu, cold, URTI; STD/genital injury or pain; dizziness; injuries; dry mouth; non-rash skin condition);elective medical procedure; mild bleeding; sunburn; tightness in head, neck
Frequency: 12 affected / 304 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 302 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 302 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 302 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 302 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 302 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 7 affected / 302 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 7 affected / 302 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: flu, cold, URTI; STD/genital injury or pain; dizziness; injuries; dry mouth; non-rash skin condition);elective medical procedure; mild bleeding; sunburn; tightness in head, neck
Frequency: 17 affected / 302 at risk
Study: NCT00358527

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 267 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 134 at risk
Study: NCT00358657

Adverse event: Hypoxia requiring mechanical ventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Pancreatitis with shock
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

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

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

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

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

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

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 14 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Haemolytic uraemic syndrome
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk
Study: NCT00358735

Adverse event: Fever due to aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 198 at risk

Adverse event: Parkinson (new event)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 198 at risk

Adverse event: supraventricular cardiac arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 198 at risk

Adverse event: Minor Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Minor bleeding was any bleeding that was not major bleeding (e.g., increased wound drainage reported by the surgeon or a drop in the hemoglobin level not requiring transfusion or prolonged hospitalization).
Frequency: 74 affected / 198 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 198 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 198 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 194 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 194 at risk

Adverse event: Stress fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 194 at risk

Adverse event: supraventricular cardiac arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 194 at risk

Adverse event: Thrombocytopenia (HIT?)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 194 at risk

Adverse event: Minor Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Minor bleeding was any bleeding that was not major bleeding (e.g., increased wound drainage reported by the surgeon or a drop in the hemoglobin level not requiring transfusion or prolonged hospitalization).
Frequency: 78 affected / 194 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 194 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 194 at risk
Study: NCT00359073

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk