TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03800030

Adverse event: Paraesthesia
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 9 affected / 24 at risk

Adverse event: Flickering lights
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 2 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 2 affected / 24 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 3 affected / 24 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 3 affected / 24 at risk

Adverse event: Neck pain
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 24 at risk

Adverse event: Local redness
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 24 at risk

Adverse event: Somnolence
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 3 affected / 24 at risk

Adverse event: Ringing noise
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 24 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 10 affected / 26 at risk

Adverse event: Flickering lights
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 4 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 5 affected / 26 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 3 affected / 26 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 3 affected / 26 at risk

Adverse event: Neck pain
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 3 affected / 26 at risk

Adverse event: Local redness
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 26 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 7 affected / 26 at risk

Adverse event: Flickering lights
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 2 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 4 affected / 26 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 5 affected / 26 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 2 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 3 affected / 26 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Investigations
Notes: Mild
Frequency: 1 affected / 26 at risk
Study: NCT03800173

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Upper airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 6 at risk

Adverse event: Gastrooesophageal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hepatic lesion
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT03800420

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

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

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

Adverse event: Gastrointestinal tract mucosal pigmentation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

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

Adverse event: Condition aggravated
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Faecal calprotectin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Stool analysis abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk
Study: NCT03800563

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: localized bleeding outside of skin blood vessels.
Frequency: 1 affected / 20 at risk

Adverse event: urinary track infection
Serious: no
Organ System: Infections and infestations
Notes: An infection in the urinary system that begins when microorganisms cling to the opening of the urethra (the canal from the bladder) and begin to multiply.
Frequency: 1 affected / 20 at risk
Study: NCT03800979

Adverse event: Intestinal tuberculosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Ileal tuberculosis
Frequency: 1 affected / 19 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Dyslipidemia (mild)
Frequency: 9 affected / 19 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory tract infection such as common cold
Frequency: 6 affected / 19 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Myalgia
Frequency: 1 affected / 19 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 19 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 19 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk
Study: NCT03801148

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Retching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 59 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 59 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 59 at risk
Study: NCT03801252

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: NICU admission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 93 at risk

Adverse event: Postpartum preeclampsia/readmission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 93 at risk
Study: NCT03801642

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Basal Cell Carcinoma Removal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Discomfort with Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 30 at risk

Adverse event: Increase in Frequency of Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: COVID-19
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 16 at risk

Adverse event: Poison Ivy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hornet Sting
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Upper Leg Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Right Big Toe Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT03801707

Adverse event: Liver enzyme elevation
Serious: no
Organ System: Hepatobiliary disorders
Notes: liver enzyme elevation \> 5 upper normal limit occurred in two patients. one patient prior to initiation of direct acting antiviral therapy, one patient during recurrence of HCV viremia in the setting of resistant mutation
Frequency: 2 affected / 30 at risk
Study: NCT03802110

Adverse event: Ventricular Fibrilation
Serious: yes
Organ System: Cardiac disorders
Notes: Failed S-ICD shock, 5 external shocks needed to convert, after start but before investigational procedure
Frequency: 1 affected / 42 at risk

Adverse event: Adverse Reaction-Allergic reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Patient condition non-cardiovascular other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Inappropriate Tachy Therapy Noise (Non-Cardiac)
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 42 at risk

Adverse event: Post surgical wound discomfort PG site (<30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Incisional/superficial infection(<30 d post implant without explant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Inadvertent Arrhythmia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 42 at risk

Adverse event: Hematoma-PG pocket (<or+ 30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 42 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: S-ICD System Procedure Related - OTHER
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Incisional/superficial infection(>30d post implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk
Study: NCT03802227

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One subject experienced back pain that was treated with paracetamol and resolved within 1-2 days. The back pain was deemed not related to the study drug (NKTR-181).
Frequency: 1 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: One subject experienced insomnia that was treated with trazodone and resolved within 1-2 days. The insomnia was deemed not related to the study drug (NKTR-181)
Frequency: 1 affected / 4 at risk
Study: NCT03802331

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Mouth injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk
Study: NCT03802344

Adverse event: Testicular seminoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 213 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 213 at risk

Adverse event: Herpes zoster meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 209 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 209 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 209 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 209 at risk

Adverse event: Cholesystitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk
Study: NCT03802565

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 82 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 87 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 87 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 87 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 87 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 87 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 83 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 85 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 85 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk
Study: NCT03802825

Adverse event: Hospitalizations
Serious: yes
Organ System: Endocrine disorders
Notes: If participants were hospitalized for any reasons related to having diabetes, then this was tracked as a serious adverse event.
Frequency: 6 affected / 54 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: If a participant had a diagnosis of hypoglycemia (low blood sugar) for any medical encounter that occurred during the study period was considered a serious adverse event.
Frequency: 1 affected / 54 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Endocrine disorders
Notes: If participants were hospitalized for any reasons related to having diabetes, then this was tracked as a serious adverse event.
Frequency: 6 affected / 56 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: If a participant had a diagnosis of hypoglycemia (low blood sugar) for any medical encounter that occurred during the study period was considered a serious adverse event.
Frequency: 1 affected / 56 at risk
Study: NCT03802864

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

Adverse event: Scrotal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

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

Adverse event: Scrotal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk