TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00675922

Adverse event: Invasive infection, MOF, death
Serious: yes
Organ System: Infections and infestations
Notes: 2001: 74% burn admitted with invasive infection, developed multi organ failure and expired. PI opinion is Adverse Event is unlikely related to study.
Frequency: 1 affected / 98 at risk

Adverse event: ischemia of leg
Serious: yes
Organ System: Vascular disorders
Notes: 2001: 80% burn patient, during Arterial IV line placement for surgery, right leg became ischemic. Anticoagulants given. Patient discharged without complications. PI opinion is Adverse Event is not related to study.
Frequency: 1 affected / 98 at risk

Adverse event: renal failure, death
Serious: yes
Organ System: Renal and urinary disorders
Notes: 2001: 90% burn admitted with renal failure. After patient was 95% grafted and healed, renal failure worsened and patient expired. PI opinion is Adverse Event unlikely related to study.
Frequency: 1 affected / 98 at risk

Adverse event: Patient aspiration and death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2001: 62% burn after discharge, patient aspirated during the night Advanced Cardiac Life Support provided, patient expired. PI opinion is Adverse Event not related to study.
Frequency: 1 affected / 98 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2001: 70% burn patient, pneumothorax occured during subclavian IV line placement for surgery. PI opinion is Adverse Event is not related to study.
Frequency: 1 affected / 98 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: 2001: 70% burn patient blood sugar decreased to 30 while on insulin drip. 2001: 70% burn patient blood glucose decreased to 35 while on insulin drip. PI opinion, Neither Adverse Event is related to study.
Frequency: 2 affected / 98 at risk

Adverse event: Sepsis, multi organ failure and death
Serious: yes
Organ System: Infections and infestations
Notes: 2001: 85% burn admitted with invasive infections became septic, developed renal failure then multi organ failure. Patient removed from respiratory support and expired. PI opinion, Adverse Event is possibly related to study.
Frequency: 1 affected / 98 at risk

Adverse event: chest tube fell out
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2001: 70% burn, chest tube fell out while patient was being moved. PI opinion, Adverse Event not related to study.
Frequency: 1 affected / 98 at risk

Adverse event: skin, opened wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 42% burn, patient fell and opened a wound in groin area. PI opinion, Adverse Event not related to study.
Frequency: 1 affected / 98 at risk

Adverse event: Wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2003: 42% burn patient scratched biopsy site that had been sutured shut, opening a wound. PI opinion, Adverse Event not related to study.
Frequency: 1 affected / 98 at risk
Study: NCT00676013

Adverse event: Aspiration and Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2001: Following discharge from hospital, patient aspirated while sleeping. Advanced Cardiac Life Support provided however patient expired. PI felt Adverse Event not related to study.
Frequency: 1 affected / 158 at risk

Adverse event: Invasive infection and death
Serious: yes
Organ System: Infections and infestations
Notes: 2001: 74% burn admitted with invasive infection. Developed multi organ failure,, coded and expired. Patient never started study. PI stated Adverse Event not related to study.
Frequency: 1 affected / 158 at risk

Adverse event: 90% burn admitted with renal failure, died
Serious: yes
Organ System: Renal and urinary disorders
Notes: 2001: 90% burn admitted with renal failure. After most of burns were grafted, renal failure worsened, patient eventually died. PI stated unlikely related to study.
Frequency: 1 affected / 158 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Notes: 2001: Arterial line placed for surgical procedure, right leg became ischemic. Treated with anticoagulants. No long term complications. PI stated not related to study.
Frequency: 1 affected / 158 at risk

Adverse event: Invasive infection, Multi organ failure, death
Serious: yes
Organ System: Infections and infestations
Notes: 2001: 85% burn patient admitted with invasive infection. Developed sepsis, renal failure, multi organ failure. Patient allowed to die.
Frequency: 1 affected / 158 at risk

Adverse event: Respiratory status compromised
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 2001: Chest tube pulled out. PI stated not related to study. 2001: Plugged Endotracheal tube x2. Endotracheal Tube pulled and replaced. PI opinion is Adverse Event is not related to study.
Frequency: 2 affected / 158 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: 2001 Patient on insulin drip, glucose decreased to 35. Glucose treated,Insulin stopped. PI opinion:not related to study. 2001: Patient on insulin drip. Glucose decreased to 30. Patient treated, insulin stopped. PI opinion:not related to study.
Frequency: 2 affected / 158 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: 2003: Hematoma following femoral IV line placement. PI opinion is Adverse Event is not related to study. 2006: hematoma developed following femoral IV line placement. PI opinion is Adverse Event is not related to study.
Frequency: 2 affected / 158 at risk

Adverse event: Fall and open wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2001: Patient fell trying to push chair and ripped skin open.
Frequency: 1 affected / 158 at risk
Study: NCT00676052

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 95 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 96 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 97 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 95 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 97 at risk
Study: NCT00676130

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 73 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 73 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 73 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 73 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 73 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 73 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 73 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 73 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 73 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 73 at risk
Study: NCT00676182

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hospitalization due to suicidal ideation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: event leading to hospitalization unknown
Frequency: 1 affected / 75 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: event unknown
Frequency: 1 affected / 75 at risk
Study: NCT00676195

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Depressive Affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 24 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 6 affected / 24 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Decreased Motor Activity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Grinding Teeth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk
Study: NCT00676585

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 25 at risk

Adverse event: New or Changed Antibiotics
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 25 at risk

Adverse event: New insulin infusion
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 25 at risk

Adverse event: Any Bleeding
Serious: no
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 25 at risk

Adverse event: New or Changed Antibiotics
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 25 at risk

Adverse event: New insulin infusion
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 25 at risk

Adverse event: Any Bleeding
Serious: no
Organ System: General disorders
Frequency: 5 affected / 25 at risk
Study: NCT00676676

Adverse event: erythema at testosterone patch site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: oily skin/acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT00676780

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Subject suffered a heart attack prior to surgery procedure. Determined to be not related to study drug.
Frequency: 1 affected / 33 at risk
Study: NCT00676793

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

Adverse event: Increase in amylase and lypase
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk
Study: NCT00676806

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gastrointestinal GVHD
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Likely d/t severe medical illness, renal failure, and medication
Frequency: 1 affected / 3 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk
Study: NCT00677014

Adverse event: PG Related
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 325 at risk

Adverse event: RA Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 325 at risk

Adverse event: RV Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 325 at risk

Adverse event: Procedure Related
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 325 at risk

Adverse event: LV Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 51 affected / 325 at risk

Adverse event: Cardiovascular Related
Serious: no
Organ System: Cardiac disorders
Frequency: 71 affected / 325 at risk

Adverse event: Death not related to any of the other Adverse Event categories
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 325 at risk

Adverse event: Non-Cardiovascular
Serious: no
Organ System: General disorders
Frequency: 7 affected / 325 at risk

Adverse event: PG Related
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 323 at risk

Adverse event: RA Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 323 at risk

Adverse event: RV Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 323 at risk

Adverse event: Procedure Related
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 323 at risk

Adverse event: LV Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 48 affected / 323 at risk

Adverse event: Cardiovascular Related
Serious: no
Organ System: Cardiac disorders
Frequency: 77 affected / 323 at risk

Adverse event: Death not related to any of the other Adverse Event categories
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 323 at risk

Adverse event: Non-Cardiovascular
Serious: no
Organ System: General disorders
Frequency: 9 affected / 323 at risk

Adverse event: PG Related
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 332 at risk

Adverse event: RA Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 332 at risk

Adverse event: RV Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 332 at risk

Adverse event: Procedure Related
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 332 at risk

Adverse event: LV Lead Related
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 332 at risk

Adverse event: Cardiovascular Related
Serious: no
Organ System: Cardiac disorders
Frequency: 88 affected / 332 at risk

Adverse event: Death not related to any of the other Adverse Event categories
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 332 at risk

Adverse event: Non-Cardiovascular
Serious: no
Organ System: General disorders
Frequency: 12 affected / 332 at risk
Study: NCT00677820

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 240 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 240 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 240 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 240 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 240 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 240 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 240 at risk

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

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Retching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk
Study: NCT00677898

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All deaths that occurred during the study were reported to the local Institutional Review Board (IRB) and were determined to be unrelated to study participation.
Frequency: 2 affected / 119 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: All deaths that occurred during the study were reported to the local Institutional Review Board (IRB) and were determined to be unrelated to study participation.
Frequency: 2 affected / 120 at risk

Adverse event: Psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: All psychiatric hospitalizations that occurred during the study were reported to the local Institutional Review Board (IRB) and were determined to be unrelated to study participation.
Frequency: 1 affected / 120 at risk
Study: NCT00678379

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Emergency Department admission
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Severe pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Emergency Department admission
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lingual nerve palsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk
Study: NCT00678444

Adverse event: Failed post-operative voiding trial
Serious: no
Organ System: Renal and urinary disorders
Notes: Failed post-operative voiding trial
Frequency: 34 affected / 93 at risk

Adverse event: Failed post-operative voiding trial
Serious: no
Organ System: Renal and urinary disorders
Notes: Failed post-operative voiding trial
Frequency: 32 affected / 91 at risk
Study: NCT00678496

Adverse event: Broken arm
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Deemed not related with the intervention, not related to natural history of MS and recovered with no sequelae.
Frequency: 1 affected / 8 at risk
Study: NCT00678639

Adverse event: Hospitalization for abdominal pain due to cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hospitalization for neck surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 53 at risk

Adverse event: Excessive cost of cardiac testing without Acute Coronary Syndrome (ACS)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Participant left before evaluation was completed
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 53 at risk

Adverse event: Hospitalization for cerebral infarct
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hospitalization for chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 57 at risk

Adverse event: Hospitalization for chest pain and suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Excessive cost of cardiac testing without Acute Coronary Syndrome (ACS)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 57 at risk

Adverse event: Participant left before evaluation was completed
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 57 at risk
Study: NCT00678691

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 28 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk