TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01580904

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 42 at risk

Adverse event: Queasiness
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 42 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 47 at risk

Adverse event: Queasiness
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 47 at risk
Study: NCT01581619

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Cellulitis
Frequency: 1 affected / 53 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 34 affected / 53 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 53 at risk

Adverse event: Soft tissue disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 53 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Reproductive system and breast disorders - Other, specify
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 53 at risk

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 53 at risk
Study: NCT01581658

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk
Study: NCT01581684

Adverse event: Feeling drunk
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chromatopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Feeling drunk
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT01581710

Adverse event: asthma exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: asthma exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk
Study: NCT01581931

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk
Study: NCT01582139

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Mild Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT01582308

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk
Study: NCT01582477

Adverse event: Post-procedural Hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT01582711

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Systemic Drug Reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: rheumatoid arthritis flare
Serious: yes
Organ System: General disorders
Notes: related to reduced efficacy of prednisone due to rifapentine
Frequency: 1 affected / 337 at risk

Adverse event: unrelated to study drug
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 337 at risk

Adverse event: Systemic Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 13 affected / 337 at risk

Adverse event: Hepatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: Neutropenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 27 affected / 337 at risk

Adverse event: unrelated to study drug
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 337 at risk

Adverse event: Systemic Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 15 affected / 337 at risk

Adverse event: Hepatitis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 337 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 36 affected / 337 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 328 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 328 at risk

Adverse event: unrelated to study drug
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 328 at risk

Adverse event: Systemic Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 14 affected / 328 at risk

Adverse event: Hepatitis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 328 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 328 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 50 affected / 328 at risk
Study: NCT01583452

Adverse event: Swallowing of chewing gum
Serious: no
Organ System: Gastrointestinal disorders
Notes: One of the patients in the intervention group accidentally swallowed the gum without any clinical implications, however with risk of intestinal obstruction
Frequency: 1 affected / 21 at risk
Study: NCT01583647

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

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk
Study: NCT01583985

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: All-cause hospitalizations
Frequency: 19 affected / 120 at risk

Adverse event: Emergency Department visits
Serious: no
Organ System: General disorders
Notes: All cause ED visits
Frequency: 58 affected / 120 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: All-cause hospitalizations
Frequency: 22 affected / 120 at risk

Adverse event: Emergency Department visits
Serious: no
Organ System: General disorders
Notes: All cause ED visits
Frequency: 49 affected / 120 at risk
Study: NCT01584388

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Notes: The Legionella infection was present unrecognised at the time of the baseline infusion
Frequency: 1 affected / 30 at risk

Adverse event: Klebsiella urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection
Frequency: 1 affected / 30 at risk

Adverse event: cold agglutininmediated
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Amaurosis fugax
Serious: yes
Organ System: Vascular disorders
Notes: amaurosis fugax leading to a carotid endarterectomy
Frequency: 1 affected / 30 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Surgery for pseudotumor
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk
Study: NCT01584518

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk
Study: NCT01585025

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT01585038

Adverse event: Dermatologic Abnormality
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash or pruritis
Frequency: 2 affected / 20 at risk

Adverse event: CNS Abnormalities
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia, Vivid Dreams, Drowsiness, Dizziness, Headache
Frequency: 11 affected / 20 at risk

Adverse event: Gastrointestinal Abnormalities
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, abdominal pain, nausea, vomiting
Frequency: 4 affected / 20 at risk

Adverse event: Dermatologic Abnormality
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash or pruritis
Frequency: 2 affected / 20 at risk

Adverse event: CNS Abnormalities
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia, Vivid Dreams, Drowsiness, Dizziness, Headache
Frequency: 6 affected / 20 at risk

Adverse event: Gastrointestinal Abnormalities
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea, abdominal pain, nausea, vomiting
Frequency: 3 affected / 20 at risk
Study: NCT01585103

Adverse event: Mucosal Tear
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 86 at risk
Study: NCT01585168

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 35 at risk

Adverse event: Lightheaded
Serious: no
Organ System: General disorders
Frequency: 19 affected / 35 at risk

Adverse event: "Drunk" or "Tipsy"
Serious: no
Organ System: General disorders
Notes: Study intervention did not involve use of alcohol, however one common side effect of the study medication includes feeling "drunk."
Frequency: 5 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 36 at risk

Adverse event: Lightheaded
Serious: no
Organ System: General disorders
Frequency: 17 affected / 36 at risk

Adverse event: "Drunk" or "Tipsy"
Serious: no
Organ System: General disorders
Notes: Study intervention did not involve use of alcohol, however one common side effect of the study medication includes feeling "drunk."
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vomit
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk
Study: NCT01585194

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

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 35 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 35 at risk

Adverse event: Increased AST
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 35 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 35 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 13 affected / 35 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 35 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 35 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 35 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 35 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 35 at risk
Study: NCT01585207

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

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

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

Adverse event: Increase in OCD symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

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

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

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

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

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

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk
Study: NCT01585324

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 30 at risk
Study: NCT01585441

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

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

Adverse event: Eye pruritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk
Study: NCT01585597

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 20 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Deep Venous Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 20 at risk
Study: NCT01586026

Adverse event: Port/Catheter Malfunction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Port would not allow for infusion of withdrawal of blood. CathFlo was administered and port functioned properly.
Frequency: 1 affected / 414 at risk

Adverse event: Port/Catheter Malfunction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Port would not allow for infusion of withdrawal of blood. CathFlo was administered and port functioned properly.
Frequency: 1 affected / 271 at risk

Adverse event: Fractured Catheter
Serious: no
Organ System: General disorders
Notes: The subject had pain radiating down the inside of the right arm during flushing. Flushing stopped and chest x-ray revealed a fractured catheter.
Frequency: 1 affected / 271 at risk
Study: NCT01586039

Adverse event: Non-serious adverse event
Serious: no
Organ System: Gastrointestinal disorders
Notes: gastroenteritis
Frequency: 1 affected / 9 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dehydration
Frequency: 1 affected / 9 at risk
Study: NCT01586065

Adverse event: Mild hypoglycemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 10 at risk
Study: NCT01586091

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 18 at risk

Adverse event: pain at the puncture site of the intravenous catheter
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: bacterial inflammation of the finger
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: pain at the puncture site of the intravenous catheter
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: pain in the knee joint
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 18 at risk
Study: NCT01586104

Adverse event: Deceased from progressive disease.
Serious: yes
Organ System: General disorders
Notes: Multi-organ failure from progressive and terminal cancer.
Frequency: 2 affected / 20 at risk