TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00368875

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 54 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 54 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 54 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 54 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 54 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 54 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 54 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 54 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 54 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 54 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 54 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 54 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 31 affected / 54 at risk
Study: NCT00368940

Adverse event: Hospitalization due to a fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 37 at risk

Adverse event: Tumor removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalization for COPD or fluid in lungs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalization due to possible stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalization due to stomach virus or ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hospitalization due to a fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 37 at risk

Adverse event: Tumor removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalization for COPD or fluid in lungs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalization due to possible stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalization following an exacerbation of scleroderma
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cataract Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 37 at risk
Study: NCT00369226

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: CTCAE grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Parainfluenzae sinusitis
Serious: yes
Organ System: Infections and infestations
Notes: CTCAE grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Cerebrovascular accident with parathesias
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: CTCAE grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: CTCAE grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Deep vein thrombosis/pulmonary embolus
Serious: yes
Organ System: Vascular disorders
Notes: CTCAE grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Clostridium difficile diarrhea
Serious: yes
Organ System: Infections and infestations
Notes: CTCAE grade 3
Frequency: 1 affected / 45 at risk

Adverse event: Coagulase-negative staphylococcal bacteremia
Serious: yes
Organ System: Infections and infestations
Notes: CTCAE grade 3
Frequency: 1 affected / 45 at risk
Study: NCT00369577

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: A 43 year-old white male with a history of schizophrenia and intravenous drug abuse (heroin and cocaine) randomized to receive placebo, was found dead on the bathroom floor next to an empty syringe 6 days after treatment.
Frequency: 1 affected / 43 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 43 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 43 at risk

Adverse event: Worsening of hypertension
Serious: yes
Organ System: Vascular disorders
Notes: A 48 year-old m with schizophrenia on treatment for hypertension received Loxapine 5 mg. While being followed up as an out-patient (11 days later), he developed worsening hypertension (BP 210/130), was hospitalized, treated, and D/C the next day
Frequency: 1 affected / 45 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 45 at risk

Adverse event: Exacerbation of schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Notes: A 23 year-old male with schizophrenia, randomized to receive Loxapine 10 mg, was hospitalized 14 days later for exacerbation of schizophrenia, agitation, noncompliance with medication taking and response to internal stimuli.
Frequency: 1 affected / 41 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 41 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 41 at risk
Study: NCT00369590

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Mouth haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: systemic hemorrhage
Frequency: 1 affected / 58 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 58 at risk

Adverse event: dysphaia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 58 at risk

Adverse event: palmar-plantar erythrodysesthesia syndrom
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: hand-foot syndrome
Frequency: 1 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 58 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 58 at risk

Adverse event: hypophosphatejia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 58 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 58 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Neutrophil count decrease
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 58 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 58 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Thrombosis/embolism
Frequency: 2 affected / 58 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk
Study: NCT00369681

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 50 at risk

Adverse event: Non-neutropenic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 50 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 50 at risk

Adverse event: Pulmonary toxicity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Other, not specified
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 50 at risk
Study: NCT00369746

Adverse event: Hospitalilization GMC
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 138 at risk

Adverse event: Medical illness without hospitalizaiton
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Psychiatric hospitalization, substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 138 at risk

Adverse event: Hospitalilization GMC
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 536 at risk

Adverse event: Medical illness without hospitalizaiton
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 536 at risk

Adverse event: Psychiatric hospitalization, substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 536 at risk

Adverse event: Death, non-suicide
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 536 at risk

Adverse event: Psychiatric hospitalization (worsening depression)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 536 at risk

Adverse event: Psychiatric hospitalization (Other)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 536 at risk
Study: NCT00369915

Adverse event: mild confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: mild confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk
Study: NCT00369928

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 85 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Alanine aminotransferase increased
Frequency: 3 affected / 85 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 85 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 85 at risk

Adverse event: Pulmonary granuloma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Alanine aminotransferase increased
Frequency: 2 affected / 85 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Alanine aminotransferase increased
Frequency: 5 affected / 86 at risk
Study: NCT00370149

Adverse event: Electromechanical Disassociation resulting in death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other Catheter related Complications
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 146 at risk

Adverse event: Respiratory Failure and Chronic lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 142 at risk

Adverse event: Other Catheter related Complications
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 142 at risk
Study: NCT00370695

Adverse event: Popliteal Aneurysm and Clot
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Increased falling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Orbital Ecchymosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT00370838

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Sad/depressed
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Psychomotor hyperactivity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Tired/sleepy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Anxious
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Sad/depressed
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tired/sleepy
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Anxious
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 10 at risk

Adverse event: Stomache ache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Sleepwalking
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT00371150

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 46 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Blood glucose abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 46 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 46 at risk
Study: NCT00371540

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Patient self prescribed and administered an herbal Abortifacient precipitating hemorrhage and death. This death was not related to the study.
Frequency: 1 affected / 96 at risk
Study: NCT00371631

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Groin pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dysreflexia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT00371644

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Some participants reported increased anxiety following participation in talk therapy.
Frequency: 3 affected / 72 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Some participants were hospitalized with symptoms related to pain, fatigue, "blacking out," and/or interpersonal violence. None of these were found to be related to their participation in talk therapy.
Frequency: 5 affected / 72 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Notes: Some participants reported increased anxiety following participation in talk therapy.
Frequency: 2 affected / 57 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Some participants were hospitalized with symptoms related to pain, fatigue, "blacking out," and/or interpersonal violence. None of these were found to be related to their participation in talk therapy.
Frequency: 3 affected / 57 at risk
Study: NCT00371839

Adverse event: Death or terminal illness
Serious: yes
Organ System: General disorders
Notes: Upon attempting to schedule an experimental session, the study team was notified of death or terminal illness of a participant, not related to study participation. No cause of death or type of illness were reported to the team.
Frequency: 6 affected / 69 at risk