TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00338039

Adverse event: Normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: allergic reaction during infusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Biliary sepsis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Sepsis/Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 69 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 69 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: associated with anorexia
Frequency: 7 affected / 69 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 69 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 69 at risk
Study: NCT00338598

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Hallucination, auditory
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT00338741

Adverse event: Premature labor/premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Two subjects had premature labor, 1 resulting in a premature delivery and the other in a stillbirth
Frequency: 2 affected / 32 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 32 at risk

Adverse event: Failed induction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: 1 for a post-date pregnancy and 1 for an SGA infant.
Frequency: 2 affected / 32 at risk

Adverse event: Failed labour progression
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 32 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 32 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 32 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 32 at risk
Study: NCT00338949

Adverse event: Psychiatric exacerbation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Psychiatric exacerbation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Akathisia
Serious: no
Organ System: Psychiatric disorders
Notes: Barnes Akathisia Scale
Frequency: 1 affected / 30 at risk
Study: NCT00338962

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject was injured at work. Death was not study related.
Frequency: 1 affected / 22 at risk

Adverse event: Incarcerated for intoxication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Hospitalized for severe anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Notes: 9 weeks after discontinuing meds
Frequency: 1 affected / 20 at risk

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

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Incarcerated for intoxication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk
Study: NCT00339079

Adverse event: Medication Switch
Serious: no
Organ System: Psychiatric disorders
Notes: 1 subject was inadvertently switched from receiving the placebo, to which she had been randomly assigned, to receiving fluoxetine, the active study medication.
Frequency: 1 affected / 44 at risk
Study: NCT00340379

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Patient fell down well and died
Frequency: 1 affected / 35 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 35 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 35 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 35 at risk

Adverse event: Muscle rigidity
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 37 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 37 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 37 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Muscle rigidity
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 37 at risk
Study: NCT00340678

Adverse event: Death from coronary artery disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Death from multiple myeloma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Death from bleeding gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Urethral obstruction after kidney biopsy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Death from coronary artery disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Death from leukemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Death from hepatocellular carcinoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 85 at risk

Adverse event: Death from alcoholic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 85 at risk

Adverse event: Death from automobile accident
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 85 at risk
Study: NCT00342563

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Psychotic Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 41 at risk

Adverse event: central nervous system symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 41 at risk

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 27 at risk

Adverse event: central nervous system symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 27 at risk

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

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 40 at risk

Adverse event: central nervous system symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 40 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 28 at risk

Adverse event: central nervous system symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 28 at risk
Study: NCT00342628

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: A 5 month old injected 1 X with Vi-rEPA died of septicemia post surgery for "nonfunctioning" kidneys. A 4 month old died of pneumonia after 2nd injection of Hib-TT. Deaths were unrelated to study, noted only because they affect the participant flow.
Frequency: 1 affected / 100 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: A 5 month old injected 1 X with Vi-rEPA died of septicemia post surgery for "nonfunctioning" kidneys. A 4 month old died of pneumonia after 2nd injection of Hib-TT. Deaths were unrelated to study, noted only because they affect the participant flow.
Frequency: 1 affected / 101 at risk
Study: NCT00343083

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: 3 patients developed a Grade IV anaphylactic reaction to the loading dose of Erbitux (week 1) and were taken off protocol hence withdrawn due to toxicity.
Frequency: 3 affected / 43 at risk
Study: NCT00343785

Adverse event: parental nutrition
Serious: yes
Organ System: Gastrointestinal disorders
Notes: mucositis requiring parental nutrition
Frequency: 3 affected / 21 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: bilirubin \> 3x ULN, cholangitis lenta
Frequency: 1 affected / 21 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: significant tinnitus in both ears with hearing loss, correctable with hearing aids
Frequency: 1 affected / 21 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

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

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

Adverse event: mucositits
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 21 at risk
Study: NCT00343863

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk
Study: NCT00344019

Adverse event: staged revasculalrization
Serious: yes
Organ System: Cardiac disorders
Notes: patient readmitted for staged coronary revascularization
Frequency: 1 affected / 97 at risk

Adverse event: increasing shortness of breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: patient admitted with increased shortness of breath. ruled out for cardiac cause. pulmonary evaluated. pt discharged home with outpatient follow up scheduled and plans for full pulmonary eval
Frequency: 1 affected / 97 at risk

Adverse event: intracranial hemmorhage
Serious: yes
Organ System: Nervous system disorders
Notes: ICH occurred one day post clinically indicated PCI. Patient's family made comfort measures and patient expired
Frequency: 1 affected / 97 at risk

Adverse event: cardiorespiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: patient found pale and non-responsive with HR 40. pt with DNR/DNI status and expired
Frequency: 1 affected / 97 at risk
Study: NCT00344032

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Lymph node tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 137 affected / 176 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 56 affected / 176 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 69 affected / 176 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 176 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 84 affected / 176 at risk

Adverse event: Fever (above 37.5 degree Celsius)
Serious: no
Organ System: General disorders
Frequency: 51 affected / 176 at risk

Adverse event: Gastro-intestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 25 affected / 176 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 72 affected / 176 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 176 at risk

Adverse event: Aborption spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 178 at risk

Adverse event: Bronchogenic cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 178 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 178 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 105 affected / 178 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 178 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 35 affected / 178 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 178 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 83 affected / 178 at risk

Adverse event: Fever (above 37.5 degree Celsius)
Serious: no
Organ System: General disorders
Frequency: 48 affected / 178 at risk

Adverse event: Gastro-intestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 28 affected / 178 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 71 affected / 178 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 178 at risk
Study: NCT00344305

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Otorrhoea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 100 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 100 at risk

Adverse event: Herpangina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 100 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 100 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 100 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 100 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 100 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 100 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 100 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk
Study: NCT00344461

Adverse event: Neutrapenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Grade 3 & 4 Liver Function Test
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Grade 4 alanine aminotransferase (ALT) test
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 54 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Stevens Johnson
Frequency: 1 affected / 54 at risk

Adverse event: Cytomegalovirus chorioretinitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 54 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk

Adverse event: Diffused Lung Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Right Femoral Deep Vein Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 54 at risk

Adverse event: Syncopy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 54 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Drug Detoxicity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Herpes Zoster Othalmicus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 54 at risk

Adverse event: Left Hand Trauma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Stabbing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Periorbital cellulitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 54 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Abscess Right Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 54 at risk
Study: NCT00344500

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 48 at risk

Adverse event: Bell's palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Staph Aureus Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Malignant Pancreatic Mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Exacerbated Psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Neurotoxic Chemical Exposure
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological effect to wood varnish fumes
Frequency: 1 affected / 48 at risk

Adverse event: Chest/rib pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 60 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 60 at risk

Adverse event: Prescription Medication Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 60 at risk

Adverse event: Syphilis Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Exacerbated Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Exacerbated Depresssion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Chest/rib pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk