TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00950352

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: A 36 year old male study participant had a suicide attempt during the eight week of the study. He ingested five Atenolol tablets (100g). Serious adverse event was unexpected and not related to the study medication (citicholine or placebo).
Frequency: 1 affected / 72 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Subject was hospitalized for sepsis due to an untreated UTI. The serious adverse event was unexpected and not related to the study medication (citicholine or placebo)
Frequency: 1 affected / 72 at risk

Adverse event: Gatsrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: General (Weight loss, Headache, Cold/flu-lie symptoms, fatigue, pulmonary)
Serious: no
Organ System: General disorders
Notes: Symptoms were assessed as "General" irrespective of the actual event
Frequency: 6 affected / 72 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 72 at risk

Adverse event: Gatsrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 32 at risk

Adverse event: General (Weight loss, Headache, Cold/flu-lie symptoms, fatigue, pulmonary)
Serious: no
Organ System: General disorders
Notes: Symptoms were assessed as "General" irrespective of the actual event
Frequency: 6 affected / 32 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 32 at risk
Study: NCT00950664

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 94 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 94 at risk

Adverse event: Pain on neck and shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 94 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 94 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 94 at risk

Adverse event: Pain on neck and shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 94 at risk
Study: NCT00950833

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 75 affected / 112 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 58 affected / 112 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 43 affected / 112 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 41 affected / 112 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 33 affected / 112 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 23 affected / 112 at risk

Adverse event: Fever/(Axillary)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 112 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 67 affected / 108 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 60 affected / 108 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 41 affected / 108 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 34 affected / 108 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 26 affected / 108 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 15 affected / 108 at risk

Adverse event: Fever/(Axillary)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 108 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 167 affected / 223 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 127 affected / 223 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 101 affected / 223 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 102 affected / 223 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 98 affected / 223 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 61 affected / 223 at risk

Adverse event: Fever/(Axillary)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 223 at risk
Study: NCT00950872

Adverse event: Gastrojejunal Anatomosis Stricture
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.
Frequency: 2 affected / 27 at risk
Study: NCT00951080

Adverse event: Maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 64 at risk

Adverse event: Allergic reaction to dressing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 64 at risk

Adverse event: Pain (wound)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 64 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 64 at risk

Adverse event: Infection of study wound (Venous Leg Ulcer)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Cellulitis right foot (Venous Leg Ulcer)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 68 at risk

Adverse event: Maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 68 at risk

Adverse event: Allergic reaction to dressing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 68 at risk

Adverse event: Pain (wound)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 68 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 68 at risk
Study: NCT00951171

Adverse event: pain with device
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 2 at risk
Study: NCT00951483

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 10 affected / 47 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 47 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: Increased irritability
Serious: no
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: Increased anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 47 at risk
Study: NCT00951821

Adverse event: Inpatient Hospitalization; ED visit
Serious: yes
Organ System: Psychiatric disorders
Notes: Evaluated or admitted secondary to suicidal ideation and/or behavior
Frequency: 5 affected / 16 at risk

Adverse event: Behavior problems involving legal authorities
Serious: no
Organ System: Psychiatric disorders
Notes: Fire setting; vanda,ism
Frequency: 2 affected / 16 at risk

Adverse event: Inpatient Hospitalization; ED visit
Serious: yes
Organ System: Psychiatric disorders
Notes: Evaluated or admitted secondary to suicidal ideation and/or behavior
Frequency: 2 affected / 8 at risk

Adverse event: Behavior problems involving legal authorities
Serious: no
Organ System: Psychiatric disorders
Notes: Fire setting; vanda,ism
Frequency: 1 affected / 8 at risk
Study: NCT00951899

Adverse event: GI ulcer and hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject experienced gastric (antral) ulcerations of unknown etiology, causing melena with acute GI blood loss.
Frequency: 1 affected / 19 at risk

Adverse event: Low hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Low hemoglobin found during visit with primary MD.
Frequency: 1 affected / 19 at risk
Study: NCT00951912

Adverse event: vignal bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 54 at risk

Adverse event: hyperplasia of mammary glands
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 54 at risk

Adverse event: thirsty
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: vignal bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: thirsty
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

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

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 56 at risk

Adverse event: thirsty
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 56 at risk
Study: NCT00952068

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 47 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 47 at risk

Adverse event: Vomiting NOS (Not Otherwise Specified)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Headache NOS (Not Otherwise Specified)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 47 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Bradychardia NOS (Not Otherwise Specified)
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 47 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk
Study: NCT00952315

Adverse event: Use of another stone breakage device intraoperatively
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 64 at risk

Adverse event: Post-operative Complications
Serious: no
Organ System: Surgical and medical procedures
Notes: Number of participants who experienced post-operative complications
Frequency: 10 affected / 64 at risk

Adverse event: Use of another stone breakage device intraoperatively
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 66 at risk

Adverse event: Post-operative Complications
Serious: no
Organ System: Surgical and medical procedures
Notes: Number of participants who experienced post-operative complications
Frequency: 10 affected / 66 at risk

Adverse event: Use of another stone breakage device intraoperatively
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 71 at risk

Adverse event: Post-operative Complications
Serious: no
Organ System: Surgical and medical procedures
Notes: Number of participants who experienced post-operative complications
Frequency: 11 affected / 71 at risk
Study: NCT00952614

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Unrelated to study activity. 29 subjects consented, 30 enrolled. 1 subject consented twice. Ocular AEs are based on 30 eyes.
Frequency: 3 affected / 23 at risk

Adverse event: Endophthalmitis
Serious: no
Organ System: Infections and infestations
Notes: Developed 1 week after implant \& resolved. Retinal Detachment (RD) developed months later; implant was removed during RD repair.

29 subjects consented, 30 enrolled. 1 subject consented twice. Ocular AEs are based on 30 eyes
Frequency: 1 affected / 29 at risk
Study: NCT00952822

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to study drug
Frequency: 1 affected / 27 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to study drug
Frequency: 1 affected / 27 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Allergy to arthropod sting
Serious: no
Organ System: Immune system disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to study drug
Frequency: 2 affected / 15 at risk

Adverse event: Device related thrombosis
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not related to study drug
Frequency: 5 affected / 15 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk

Adverse event: Joint range of motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to study drug
Frequency: 1 affected / 15 at risk
Study: NCT00952848

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to intervention.
Frequency: 1 affected / 18 at risk
Study: NCT00953017

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of nausea
Frequency: 2 affected / 101 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal cramping
Frequency: 4 affected / 101 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal bloating
Frequency: 1 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of nausea
Frequency: 3 affected / 101 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal cramping
Frequency: 2 affected / 101 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal bloating
Frequency: 2 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of nausea
Frequency: 6 affected / 100 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal cramping
Frequency: 2 affected / 100 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal bloating
Frequency: 2 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of nausea
Frequency: 4 affected / 101 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal cramping
Frequency: 4 affected / 101 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: questionnaire used to identify any patient complaints of abdominal bloating
Frequency: 1 affected / 101 at risk
Study: NCT00953043

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk
Study: NCT00953160

Adverse event: Lumps
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 49 at risk
Study: NCT00953212

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 76 at risk

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 74 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 74 at risk

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 78 at risk

Adverse event: Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 76 at risk
Study: NCT00953290

Adverse event: Erythema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4 at risk

Adverse event: Oedema
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4 at risk

Adverse event: Lumps
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4 at risk

Adverse event: Sensitivity
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4 at risk

Adverse event: Discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4 at risk
Study: NCT00953615

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

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

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

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

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

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk
Study: NCT00953667

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 400 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 400 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 400 at risk

Adverse event: >2g drop in Hgb or <10 g/dL
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: \> 2g drop in Hgb from baseline or \<10 g/dL Hgb at discharge
Frequency: 18 affected / 400 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Notes: subject reported lightheadedness or dizziness
Frequency: 15 affected / 400 at risk
Study: NCT00953680

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 76 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 76 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 77 at risk