TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01257438

Adverse event: Infection in the AVF venous cannulation site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: infection of the old stent in the fistula
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: arm or hand edema
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 128 at risk

Adverse event: rash on arm due to allergic reaction to unknown source
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 128 at risk

Adverse event: fever/cellulitis of both legs/sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 128 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 128 at risk

Adverse event: Arm or Hand Edema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 128 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 128 at risk

Adverse event: Allergic reaction. to uncertain source; rash on right arm
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Fever/cellulitis of both legs/sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 128 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Infection in the AVF venous cannulation site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 137 at risk

Adverse event: vessel rupture
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 137 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 137 at risk

Adverse event: rash on arm due to allergic reaction to unknown source
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 137 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 137 at risk

Adverse event: Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 137 at risk

Adverse event: Vessel Rupture
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 137 at risk

Adverse event: Infolded covered stent
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 137 at risk

Adverse event: Prolonged Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 137 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 137 at risk
Study: NCT01257542

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Choking
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk
Study: NCT01257568

Adverse event: Operative Site
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Operative Site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Operative Site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 42 at risk

Adverse event: Operative Site
Serious: yes
Organ System: Product Issues
Frequency: 22 affected / 42 at risk

Adverse event: Operative Site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 42 at risk

Adverse event: Operative Event
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 42 at risk

Adverse event: Systemic Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Systemic Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Systemic Event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

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

Adverse event: Systemic Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Systemic Events
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 40 at risk
Study: NCT01257750

Adverse event: Tearing
Serious: no
Organ System: Eye disorders
Notes: Unilateral tearing secondary to punctal occlusion.
Frequency: 10 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: Eye disorders
Notes: Transitory stinging directly related to drug instillation.
Frequency: 4 affected / 20 at risk

Adverse event: Dryness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Blurred vision after drug instillation.
Frequency: 1 affected / 20 at risk
Study: NCT01258049

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 77 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 77 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 77 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 77 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 77 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 77 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 77 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 77 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 74 at risk

Adverse event: Cerebral malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 74 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 74 at risk

Adverse event: Malaria
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 74 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 74 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 74 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 74 at risk
Study: NCT01258153

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Infrequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Gamma -GT abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 at risk

Adverse event: Apnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Regurgitation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization for Bronchitis in a 10 weeks-old male infant. The investigator considered the SAE as unlikely related to the study drug. It resolved without sequel.
Frequency: 1 affected / 38 at risk

Adverse event: Salivary ipersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 38 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Crying
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk
Study: NCT01258504

Adverse event: feeling of heat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 13 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: increase of alanine aminotransferase
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: pressure sensation in the head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: epigastric pressure sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: strained muscle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 13 at risk

Adverse event: increase of alanine aminotransferase
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: pressure sensation in the head
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: epigastric pressure sensation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: strained muscle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: ocular itching with secretion of tears
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk
Study: NCT01258582

Adverse event: False-positive rapid test result
Serious: no
Organ System: Investigations
Frequency: 1 affected / 553 at risk

Adverse event: Subject did not follow-up after reactive test
Serious: no
Organ System: Investigations
Frequency: 1 affected / 553 at risk

Adverse event: Subject did not follow-up after reactive test
Serious: no
Organ System: Investigations
Frequency: 1 affected / 565 at risk
Study: NCT01258595

Adverse event: Solicited Injection Site Pain
Serious: no
Organ System: General disorders
Frequency: 112 affected / 148 at risk

Adverse event: Solicited Injection Site Erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 147 at risk

Adverse event: Solicited Injection Site Swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 147 at risk

Adverse event: Solicited Injection Site Induration
Serious: no
Organ System: General disorders
Frequency: 13 affected / 147 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 44 affected / 147 at risk

Adverse event: Solicited Shivering
Serious: no
Organ System: General disorders
Frequency: 29 affected / 147 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 70 affected / 147 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 147 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 148 at risk

Adverse event: Solicited Injection Site Pain
Serious: no
Organ System: General disorders
Frequency: 85 affected / 152 at risk

Adverse event: Solicited Injection Site Erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 152 at risk

Adverse event: Solicited Injection Site Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 152 at risk

Adverse event: Solicited Injection Site Induration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 152 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 38 affected / 152 at risk

Adverse event: Solicited Shivering
Serious: no
Organ System: General disorders
Frequency: 21 affected / 152 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 152 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 152 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 152 at risk
Study: NCT01258790

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

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

Adverse event: Mild headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT01259024

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: generalized fatigue
Frequency: 1 affected / 1 at risk

Adverse event: right groin burning pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Burning to right groin with post-procedure hematoma
Frequency: 1 affected / 1 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: low back pain
Frequency: 1 affected / 1 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: anorexia
Frequency: 1 affected / 1 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea
Frequency: 1 affected / 1 at risk
Study: NCT01259284

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

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypotension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT01259388

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

Adverse event: Excess thirst
Serious: no
Organ System: General disorders
Frequency: 18 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 23 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 23 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 13 affected / 23 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 10 affected / 23 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 23 at risk

Adverse event: Cognitive change
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 23 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 23 at risk

Adverse event: Gait impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 23 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 23 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 23 at risk

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

Adverse event: Unusual dreams
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hospitalization to place suprapubic catheter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk
Study: NCT01259401

Adverse event: Wrist abrasion from actigraph
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Wrist abrasion from actigraph
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk
Study: NCT01259427

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: All psychiatric hospitalizations that occurred during the study were reported to the local IRB and unrelated to study participation
Frequency: 5 affected / 124 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All deaths that occurred during the study were reported to the local IRB and were determined to be unrelated to study participation
Frequency: 1 affected / 124 at risk

Adverse event: Medical Hospitalization
Serious: yes
Organ System: General disorders
Notes: All medical hospitalizations that occurred during the study were reported to the local IRB and unrelated to study participation
Frequency: 1 affected / 124 at risk

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: All psychiatric hospitalizations that occurred during the study were reported to the local IRB and unrelated to study participation
Frequency: 5 affected / 124 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All deaths that occurred during the study were reported to the local IRB and were determined to be unrelated to study participation
Frequency: 2 affected / 124 at risk
Study: NCT01259596

Adverse event: Adverse event
Serious: no
Organ System: Psychiatric disorders
Notes: 1SD increase in either PSWQ-A or BDI scores
Frequency: 4 affected / 70 at risk

Adverse event: Adverse event
Serious: no
Organ System: Psychiatric disorders
Notes: 1SD increase in either PSWQ-A or BDI scores
Frequency: 4 affected / 71 at risk