TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00767364

Adverse event: Low hemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Occurred in 1 participant, resolved
Frequency: 1 affected / 5 at risk

Adverse event: Elevated Bilirubin level
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Likely due to Chronic TPN use
Frequency: 1 affected / 5 at risk

Adverse event: Fever, Rule out catheter infection
Serious: yes
Organ System: Infections and infestations
Notes: Fever and Central catheter, evaluated as Rule out Sepsis
Frequency: 2 affected / 5 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Positive Central Catheter infection, Treatment required inpatient stay
Frequency: 1 affected / 5 at risk

Adverse event: Bowel obstruction; Hirschsprung enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Due to underlying disease, required inpatient stay
Frequency: 1 affected / 5 at risk

Adverse event: Stomal bleeding - hematochezia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Transient stomal site bleeding
Frequency: 2 affected / 5 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Notes: No stomal site
Frequency: 1 affected / 5 at risk

Adverse event: Gastrostomy tube drainage after removal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting with diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fussiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fever with upper respiratory infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

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

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

Adverse event: Fussiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT00767455

Adverse event: Tape Reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: None of the adverse events were related to the test article. The four (4) subjects with a moderate adverse event due to tape irritation were discontinued from the study
Frequency: 4 affected / 59 at risk
Study: NCT00767624

Adverse event: Severe vaginal bleeding and pain
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Medical event requiring hospitalization.
Frequency: 1 affected / 75 at risk

Adverse event: Chest pain in a patient with CAD
Serious: yes
Organ System: Cardiac disorders
Notes: Medical event requiring hospitalization
Frequency: 1 affected / 75 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Medical event requiring hospitalization The person experiencing this event had another serious adverse event
Frequency: 1 affected / 75 at risk

Adverse event: Hematoma R side abdomen
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Medical event requiring hospitalization The person experiencing this event had another SAE event
Frequency: 1 affected / 75 at risk

Adverse event: suicidal ideation and worsening depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychiatric event
Frequency: 1 affected / 75 at risk

Adverse event: Worsening of known cardiac condition
Serious: yes
Organ System: Cardiac disorders
Notes: Medical event requiring hospitalization . Event was not expected and was not related to study meds
Frequency: 1 affected / 75 at risk

Adverse event: Medically significant event not requiring hospitalization
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: slipped on street curb and broke wrist
Frequency: 1 affected / 75 at risk
Study: NCT00767767

Adverse event: Extreme Fidgety
Serious: no
Organ System: General disorders
Notes: Extremely fidgety, dosing on and off, requiring prompting
Frequency: 1 affected / 20 at risk
Study: NCT00768053

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 108 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 108 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 108 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 18 affected / 108 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 108 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 108 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 108 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 108 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 108 at risk
Study: NCT00768222

Adverse event: Deep incisional SSI
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Skin lymphangitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 50 at risk

Adverse event: Skin necrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 50 at risk

Adverse event: Myelosuppression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 51 at risk
Study: NCT00768430

Adverse event: Hypotension/Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension (BP=73/40 for 1 min)/bradycardia (HR \<30 bpm for 30 sec, followed by spontaneous recovery). This occurred while the subject was undergoing venipuncture at the 30 min time point and was considered a vaso- vagal episode.
Frequency: 1 affected / 47 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Social circumstances
Notes: Suicide Attempt: While tapering off of psychotropic medication, patient was hospitalized following an attempted overdose.
Frequency: 1 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 47 at risk

Adverse event: Dizziness on standing
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 47 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 47 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: Dizziness on standing
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 25 at risk
Study: NCT00768521

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT00768560

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

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

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

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

Adverse event: Lipid metabolism disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Lipid metabolism disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 34 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 34 at risk

Adverse event: Carotid arteriosclerosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 34 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 34 at risk
Study: NCT00768651

Adverse event: Nausea or Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk
Study: NCT00769015

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 96 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 96 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 96 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 96 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 96 at risk

Adverse event: Break/fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 96 at risk

Adverse event: GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 96 at risk

Adverse event: falls with no break/uti
Serious: no
Organ System: General disorders
Frequency: 11 affected / 96 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 92 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 92 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 92 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 92 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 92 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 92 at risk

Adverse event: Break/fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 92 at risk

Adverse event: GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 92 at risk

Adverse event: falls with no break/uti
Serious: no
Organ System: General disorders
Frequency: 5 affected / 92 at risk
Study: NCT00769184

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: One subject was removed from the study due to a treatment-related adverse event involving contact dermatitis with clobetasol, LCD, and vehicle with bilateral itching.
Frequency: 1 affected / 15 at risk

Adverse event: Bilateral Worsening of Plaque Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Two subjects were removed from the study due to treatment-related bilateral worsening of their psoriasis.
Frequency: 1 affected / 15 at risk

Adverse event: Bilateral Worsening of Plaque Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Two subjects were removed from the study due to treatment-related bilateral worsening of their psoriasis.
Frequency: 1 affected / 15 at risk
Study: NCT00769314

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 378 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 378 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 378 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 378 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 397 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 397 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 397 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 397 at risk
Study: NCT00769379

Adverse event: Troponin I increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 998 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 998 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 998 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 998 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 80 affected / 998 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 261 affected / 998 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 990 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 990 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 990 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 990 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 990 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 990 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 990 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 990 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 990 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 990 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 990 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 990 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 77 affected / 990 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 208 affected / 990 at risk
Study: NCT00769392

Adverse event: Subconjunctival Hemorrage with Lidocaine subconjunctival injection
Serious: no
Organ System: Eye disorders
Notes: Subconjunctival Hemorrage occurrence with Lidocaine subconjunctival injection
Frequency: 13 affected / 24 at risk
Study: NCT00769561

Adverse event: Pain in teeth
Serious: no
Organ System: Nervous system disorders
Notes: Patient reported symptom aggravation, namely pain in teeth.
Frequency: 1 affected / 29 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported symptom aggravation, namely jaw pain
Frequency: 1 affected / 29 at risk

Adverse event: Limited jaw motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported symptom aggravation, namely limited jaw motion
Frequency: 1 affected / 29 at risk

Adverse event: Pain in teeth
Serious: no
Organ System: Nervous system disorders
Notes: Patient reported symptom aggravation, namely pain in teeth.
Frequency: 1 affected / 29 at risk

Adverse event: Limited jaw motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported symptom aggravation, namely limited jaw motion
Frequency: 1 affected / 29 at risk

Adverse event: Higher muscle tension
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported symptom aggravation, namely higher muscle tension
Frequency: 1 affected / 29 at risk

Adverse event: Pain in head and/or back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported symptom aggravation, namely aggravation of pain in head and/or back
Frequency: 2 affected / 29 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Patient reported symptom aggravation, namely ear pain
Frequency: 1 affected / 29 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Patient reported aggravation of pre-existing tinnitus
Frequency: 1 affected / 29 at risk
Study: NCT00769600

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Intratumoral Bleed
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 15 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT00769808

Adverse event: Bowman's membrane disorder
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 66 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 66 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 66 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 36 affected / 66 at risk

Adverse event: Ocular procedural complication
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 66 at risk