TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01819506

Adverse event: subsequent stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Fall
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Fell on bus
Frequency: 1 affected / 51 at risk

Adverse event: sick
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: cardiac problems
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: subsequent stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 52 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 52 at risk
Study: NCT01819597

Adverse event: Death with 30 days of surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Death 28 days after the EDAS surgery in a 70 y/o patient who suffered a large myocardial infarction three weeks after surgery and secondary cardiac tamponade.
Frequency: 1 affected / 52 at risk

Adverse event: Wound dehiscenece
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Surgical wound dehiscence that required an additional surgical intervention for debridement and closure.
Frequency: 2 affected / 52 at risk
Study: NCT01819831

Adverse event: Dehiscence
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk
Study: NCT01819922

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

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01820611

Adverse event: Deep Infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Deep infection \< 6 weeks
Frequency: 3 affected / 74 at risk

Adverse event: Dislocation and Sublaxation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dislocation
Frequency: 3 affected / 74 at risk

Adverse event: Femoral Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Femoral Pain
Frequency: 2 affected / 74 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fracture of femoral shaft and trochanter
Frequency: 3 affected / 74 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hematoma
Frequency: 1 affected / 74 at risk

Adverse event: Instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 74 at risk

Adverse event: Nerve and vascular deficit
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Nerve and vascular deficit
Frequency: 2 affected / 74 at risk

Adverse event: Superficial Infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Superficial Infection
Frequency: 1 affected / 74 at risk

Adverse event: Wound Drainage and Dehiscence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Wound Drainage and Dehiscence
Frequency: 5 affected / 74 at risk

Adverse event: Other Hip Related Adverse Events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain, trochanteric bolt loosening, contralateral hip surgery, leg reddening, hip athrosis, wound secretion
Frequency: 12 affected / 74 at risk

Adverse event: General Complications
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection, Urinary tract infection and infection
Frequency: 9 affected / 74 at risk

Adverse event: General Complications
Serious: no
Organ System: Nervous system disorders
Notes: Nerve injury and stroke
Frequency: 4 affected / 74 at risk
Study: NCT01821300

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation due to physical activity armband wear. If irritation occurred armband wear was discontinued.
Frequency: 5 affected / 154 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting in reaction to glucola ingestion associated with oral glucose tolerance test.
Frequency: 1 affected / 154 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycemia occurring during oral glucose tolerance test. Test prematurely stopped so that participant could ingest food.
Frequency: 1 affected / 154 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation due to physical activity armband wear. If irritation occurred armband wear was discontinued.
Frequency: 2 affected / 103 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: Fainting in reaction to blood draw.
Frequency: 1 affected / 103 at risk
Study: NCT01821560

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 22 at risk

Adverse event: Dizzy/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cognitive Changes
Serious: no
Organ System: Nervous system disorders
Notes: vivid Dreams, nightmares, mental fogginess
Frequency: 2 affected / 22 at risk

Adverse event: Elevated Blood Pressure
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Digestive
Serious: no
Organ System: Gastrointestinal disorders
Notes: gas, heartburn, increased appetite, decreased appetite, bowel changes, diarrhea, stomach pain
Frequency: 4 affected / 22 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Dizzy/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Cognitive Changes
Serious: no
Organ System: Nervous system disorders
Notes: vivid Dreams, nightmares, mental fogginess
Frequency: 4 affected / 22 at risk

Adverse event: Affective Changes
Serious: no
Organ System: Psychiatric disorders
Notes: irritability, mood swings
Frequency: 4 affected / 22 at risk

Adverse event: Elevated Blood Pressure
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 22 at risk

Adverse event: Digestive
Serious: no
Organ System: Gastrointestinal disorders
Notes: gas, heartburn, increased appetite, decreased appetite, bowel changes, diarrhea, stomach pain
Frequency: 4 affected / 22 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: muscle weakness
Frequency: 2 affected / 22 at risk
Study: NCT01821625

Adverse event: Variceal hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Self-limited GI bleeding as can be seen in cirrhosis.
Frequency: 1 affected / 7 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: prior skin ulcer on leg exacerbation
Frequency: 1 affected / 7 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Nervous system disorders
Notes: Flu like symptoms due to interferon therapy
Frequency: 1 affected / 7 at risk
Study: NCT01821807

Adverse event: Postdural puncture headache
Serious: yes
Organ System: Nervous system disorders
Notes: Postdural puncture headache (PDPH), a common side effect after spinal anesthesia. Can be serious.
Frequency: 14 affected / 147 at risk

Adverse event: Postdural puncture backache
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Postdural puncture backache (PDPB), a common side effect after spinal anesthesia. Rarely necessitates intervention.
Frequency: 65 affected / 147 at risk

Adverse event: Epidural hemathoma
Serious: no
Organ System: Nervous system disorders
Notes: One patient had experienced intracranial epidural hemathoma. It was linked to the minor head trauma 3 days before the operation, which was missed out in the anamnesis.
Frequency: 1 affected / 147 at risk

Adverse event: Postdural puncture headache
Serious: yes
Organ System: Nervous system disorders
Notes: Postdural puncture headache (PDPH), a common side effect after spinal anesthesia. Can be serious.
Frequency: 10 affected / 109 at risk

Adverse event: Postdural puncture backache
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Postdural puncture backache (PDPB), a common side effect after spinal anesthesia. Rarely necessitates intervention.
Frequency: 68 affected / 109 at risk

Adverse event: Sinus rhythm pause
Serious: no
Organ System: Cardiac disorders
Notes: Sinus rhythm cessation for at least 3 seconds. Our patient had 6 second pause.
Frequency: 1 affected / 109 at risk
Study: NCT01821963

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1 at risk

Adverse event: Nonoliguric acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1 at risk
Study: NCT01822119

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Post procedural heamatoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Implant site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk
Study: NCT01822301

Adverse event: Contusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 5 at risk

Adverse event: Swelling
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 5 at risk

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 5 at risk
Study: NCT01822353

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Use of epinephrin because of allergic symptoms
Frequency: 2 affected / 10 at risk

Adverse event: Mouth and throat itching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 10 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Use of epinephrin because of allergic symptoms
Frequency: 1 affected / 9 at risk

Adverse event: Mouth and throat itching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: Mouth and throat itching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk
Study: NCT01822535

Adverse event: Autonomic dysreflexia
Serious: yes
Organ System: Nervous system disorders
Notes: Subject experienced autonomic dysreflexia (i.e. increased blood pressure, decreased heart rate, diaphoresis) due to a need to be catheterized. Once catheterized, subject's blood pressure and heart rate returned to normal.
Frequency: 1 affected / 17 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject experienced neck pain due to excessive muscle tightness, secondary to cold exposure.
Frequency: 1 affected / 17 at risk

Adverse event: Autonomic dysreflexia
Serious: yes
Organ System: Nervous system disorders
Notes: Subject experienced autonomic dysreflexia (i.e. increased blood pressure, decreased heart rate, diaphoresis) due to a need to be catheterized. Once catheterized, subject's blood pressure and heart rate returned to normal.
Frequency: 1 affected / 11 at risk
Study: NCT01822548

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: At each study visit side effects were systematically investigated and patients were asked to contact the centre in case of adverse events.
Frequency: 5 affected / 24 at risk
Study: NCT01822561

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One patient stopped treatment after 2 weeks because of subjective shortness of breath. Symptoms resolved within 1 day of stopping the medication.
Frequency: 1 affected / 15 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: One patient stopped treatment after experiencing subjective headache and heart palpitations after a single dose. Symptoms resolved within 1 day of stopping the medication.
Frequency: 1 affected / 15 at risk
Study: NCT01822587

Adverse event: Participant Hospitalization
Serious: no
Organ System: Psychiatric disorders
Notes: Participant was hospitalized for depression and suicidal thoughts (no attempt).
Frequency: 1 affected / 1 at risk
Study: NCT01822665

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Gastritis erosive
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
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: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk
Study: NCT01822678

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 57 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 40 at risk
Study: NCT01822886

Adverse event: Fever with shiver, Hypotension, Desaturation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Fever, loss of consciousness and urinary infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Ischaemic encephalopaty
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 20 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 20 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 20 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Transaminases increase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 20 at risk
Study: NCT01822899

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 358 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 358 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 358 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 358 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 358 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 358 at risk

Adverse event: Skin burning sensation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 358 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 358 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 358 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 358 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 358 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 358 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 358 at risk
Study: NCT01823107

Adverse event: Seroma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 25 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Skin flap necrosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk
Study: NCT01823224

Adverse event: Hospitalization greater 24 hours
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: hospitalizatoin
Serious: no
Organ System: Cardiac disorders
Notes: This subject had a planned admit and was in greater than 24 hours after the surgery, she had a cardiac history and was kept as a precaution
Frequency: 1 affected / 28 at risk

Adverse event: ER visit
Serious: no
Organ System: Renal and urinary disorders
Notes: subject came to the ER POD 1 for urinary retention post catheter removal, IRB informed but determined non related. She was sent home again.
Frequency: 1 affected / 28 at risk