TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00064298

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

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 68 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 68 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 68 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 68 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 68 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 68 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Mood altered
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 59 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 59 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: Taste disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk
Study: NCT00064753

Adverse event: Gastrointestinal disturbances
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 121 affected / 2056 at risk

Adverse event: Gastrointestinal disturbances
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 114 affected / 2054 at risk
Study: NCT00064792

Adverse event: Muscle Pain and Elevated CK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk
Study: NCT00064844

Adverse event: bleeding gums
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: bleeding gums
Serious: no
Organ System: General disorders
Frequency: 7 affected / 51 at risk

Adverse event: jaw ache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk
Study: NCT00065260

Adverse event: Infection
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 27 at risk

Adverse event: Infection
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 27 at risk

Adverse event: Infection
Serious: yes
Organ System: Immune system disorders
Frequency: 12 affected / 27 at risk

Adverse event: Infection
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 27 at risk
Study: NCT00065611

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mood swings
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Muscle pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Acute appendicitis, increased intraocular pressure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mood swings
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Change in appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Impaired glucose tolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cushingoid appearance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk
Study: NCT00066066

Adverse event: hospitalizations
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 27 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 27 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: hospitalizations
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 30 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One death was due to cancer - SRP/MET/NonSmoker Group One death due to unknown causes
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 30 at risk

Adverse event: hospitalizations
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 20 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: hospitalizations
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 27 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: One death was due to cancer - SRP/MET/NonSmoker Group One death due to unknown causes
Frequency: 1 affected / 27 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: hospitalizations
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 20 at risk
Study: NCT00066807

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk
Study: NCT00066937

Adverse event: drymouth
Serious: no
Organ System: General disorders
Frequency: 20 affected / 41 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 41 at risk

Adverse event: drymouth
Serious: no
Organ System: General disorders
Frequency: 14 affected / 38 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: drymouth
Serious: no
Organ System: General disorders
Frequency: 13 affected / 37 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 37 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 37 at risk

Adverse event: drymouth
Serious: no
Organ System: General disorders
Frequency: 9 affected / 24 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk
Study: NCT00066963

Adverse event: Ulcer on the cheek
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Upon questioning, a parent reported at the 18-month visit the child had an "ulcer on the cheek" onsetting 2 months after the last fluoride varnish application, which was a "fluoride-free" placebo application. The ulcer was gone at the 24-month visit.
Frequency: 1 affected / 87 at risk
Study: NCT00068575

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 28 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 28 at risk

Adverse event: Febrile (Non-neutropenic)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Elevated alkaline phosphate
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Elevated Alanine transaminase (ALT)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 28 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 28 at risk

Adverse event: Hand/foot syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 28 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Mucositis/Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 28 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Overdose of interferon alfa-2b (IFN)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk
Study: NCT00068718

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 35 at risk

Adverse event: Myocardial infaction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Secondary Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Graft versus host disease
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Respiratory, thoracic, and mediastrinal disorders - Other (Unknown)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Spleen disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Metabolism and nutrition disorders - Other (Elevated tacrolimus level)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Second primary malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 35 at risk
Study: NCT00068822

Adverse event: Surgical injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: One participant in the vertebroplasty group had an injury to the thecal sac during the procedure resulting in hospitalization.
Frequency: 1 affected / 68 at risk

Adverse event: Tachycardia and rigors
Serious: yes
Organ System: Cardiac disorders
Notes: One patient in the control group was hospitalized overnight after the procedure with tachycardia and rigors of unknown cause
Frequency: 1 affected / 61 at risk
Study: NCT00069823

Adverse event: Asthma exacerbation requiring hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 193 at risk

Adverse event: Hospitalization or emergency department visit for surgery, trauma, or other acute illness
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 193 at risk

Adverse event: Hospitalization for possible cardiac ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 193 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 143 at risk

Adverse event: Asthma exacerbation requiring hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 203 at risk

Adverse event: Hospitalization or emergency department visit for surgery, trauma, or other acute illness
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 203 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Death from complications after surgery for endobronchial tumor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk
Study: NCT00070070

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

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 5 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk
Study: NCT00070291

Adverse event: Hematologic-other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Leukopenia (Leukocytes, decreased)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Neutropenia (Neutrophils, decreased)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia (Platelets, decreased)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infection w/ gr3-4 neut, urinary tract
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Creatinine, increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Metabolic/Laboratory-other
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Neuropathy-sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Extremity-limb, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Muscle, pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT00070317

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 89 at risk

Adverse event: Other Blood/Bone Marrow
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: Constitutional Symptoms
Serious: no
Organ System: General disorders
Frequency: 8 affected / 89 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Other Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 89 at risk

Adverse event: Lymphocele
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Other Lymphatics
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Metabolic/Laboratory
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 89 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 89 at risk

Adverse event: Renal/Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 89 at risk

Adverse event: Intra-Op Injury: Ureter
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 89 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 89 at risk
Study: NCT00070707

Adverse event: Fracture, bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 113 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 113 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 75 at risk