TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00734097

Adverse event: Dizziness / Hypotension / Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 317 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 317 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 317 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 317 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 317 at risk
Study: NCT00734214

Adverse event: Generalised oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 128 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 130 at risk

Adverse event: New onset Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 130 at risk
Study: NCT00734409

Adverse event: Unplanned Self-Device Removal Event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 145 at risk
Study: NCT00734500

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac and respiratory failure - family withdrew care - patient died soon after administration of 1st dose of study drug.
Frequency: 1 affected / 15 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 subjects experienced direct hyperbilirubinemia possibly related to study drug; study drug was stopped in 1 of these patients. Both patients had history of previous hyperbilirubinemia episodes.
Frequency: 2 affected / 15 at risk
Study: NCT00734630

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 233 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 233 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 233 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 233 at risk
Study: NCT00734656

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 78 at risk

Adverse event: Headace
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Libido, reduced
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 78 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 81 at risk

Adverse event: Headace
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 81 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 81 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 81 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Headace
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 83 at risk

Adverse event: Libido, reduced
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 83 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 83 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Headace
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 78 at risk
Study: NCT00734734

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 64 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk
Study: NCT00734747

Adverse event: Upper GI bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pain and fever
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 72 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 72 at risk

Adverse event: Suicidal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pleural effusion, esophageal leak
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pneumothorax/pneumoperitoneum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 72 at risk

Adverse event: Increase belching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 72 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 72 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 72 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 72 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 72 at risk
Study: NCT00734903

Adverse event: adverse events
Serious: yes
Organ System: Investigations
Notes: All were determined to be unrelated to the study and study treatments, per the IRB of record.
Frequency: 4 affected / 33 at risk

Adverse event: adverse events
Serious: yes
Organ System: Investigations
Notes: All were determined to be unrelated to the study and study treatments, per the IRB of record.
Frequency: 7 affected / 33 at risk
Study: NCT00734994

Adverse event: Abdominal / pelvic discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Complaint of discomfort during or post hyperthermia treatment
Frequency: 6 affected / 15 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 15 at risk

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

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

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

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

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

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

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 15 at risk

Adverse event: Induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 15 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Urethral pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 15 at risk

Adverse event: Urinary Tract Infection - suspected
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 15 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Not due to infection
Frequency: 1 affected / 2 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk
Study: NCT00735072

Adverse event: Indirect Hyperbilirubinemia (on atazanavir-based ART)
Serious: no
Organ System: Hepatobiliary disorders
Notes: All cases were comparable to baseline values and all were on atazanavir-based regimens. None required treatment change during the trial.
Frequency: 2 affected / 23 at risk

Adverse event: Prolonged Fever
Serious: no
Organ System: Infections and infestations
Notes: Unexplained fever for 2 weeks without identifiable cause, resolved in absence of any specific therapy and subject had continued study medication without recurrence.
Frequency: 1 affected / 23 at risk

Adverse event: Triglyceride Elevation
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 trygliceride elevation noted, comparable to recent values prior to enrollment and resolved to baseline values without change in therapy.
Frequency: 1 affected / 23 at risk

Adverse event: Indirect Hyperbilirubinemia (on atazanavir-based ART)
Serious: no
Organ System: Hepatobiliary disorders
Notes: All cases were comparable to baseline values and all were on atazanavir-based regimens. None required treatment change during the trial.
Frequency: 1 affected / 22 at risk

Adverse event: HBV flare, transaminitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Subject stopped all ARVs and study medications due to a lapse in insurance coverage (and didnt notify physician or study team). Had a recurrence of HBV viremia with transaminitis (after discontinuing study medication), resolved after restarting ART.
Frequency: 1 affected / 22 at risk
Study: NCT00735306

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 12 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 12 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk
Study: NCT00735449

Adverse event: Acute exacerbation of COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Bacterial bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk
Study: NCT00735462

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 201 at risk

Adverse event: Ovarian cystectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 201 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 201 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 14 affected / 201 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 201 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Frequency: 3 affected / 201 at risk

Adverse event: Application site ulcer
Serious: no
Organ System: General disorders
Frequency: 3 affected / 201 at risk

Adverse event: Application site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 201 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 205 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 205 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 205 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 205 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 205 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 7 affected / 205 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 11 affected / 205 at risk

Adverse event: Application site rash
Serious: no
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Application site ulcer
Serious: no
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Application site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Application site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk
Study: NCT00735670

Adverse event: kidney infection (unrelated)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Subject was hospitalized with kidney infection which was determined to be unrelated to the study.
Frequency: 1 affected / 10 at risk

Adverse event: Side effects
Serious: no
Organ System: General disorders
Notes: Includes side effects of feeling "spacey", sleepiness, drowsiness, sexual dysfunction, irritability.
Frequency: 3 affected / 10 at risk

Adverse event: Suddenly stopped taking medication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Side effects
Serious: no
Organ System: General disorders
Notes: Includes side effects of feeling "spacey", sleepiness, drowsiness, sexual dysfunction, irritability.
Frequency: 4 affected / 11 at risk

Adverse event: Onset of major depressive episode
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk
Study: NCT00735839

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 30 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

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

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT00735878

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

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 14 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

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

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

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk
Study: NCT00735943

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Subretinal fibrosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk
Study: NCT00735969

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk
Study: NCT00736034

Adverse event: gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hepatitis
Serious: no
Organ System: General disorders
Notes: Not related
Frequency: 1 affected / 18 at risk
Study: NCT00736073

Adverse event: ERCP pancreatitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 34 at risk

Adverse event: ERCP pancreatitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 39 at risk
Study: NCT00736190

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 90 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 90 at risk
Study: NCT00736229

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 40 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Drug failure
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: If at anytime after 6 hours of study drug administration there are four consecutive fingerstick glucose levels greater than 200 mg/dL the nurse caring for participant will classify drug failure.
Frequency: 3 affected / 40 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 40 at risk