Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 12:57 PM
Ignite Modification Date: 2025-12-25 @ 12:18 PM
NCT ID: NCT00816361
Description: None
Frequency Threshold: 0
Time Frame: From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
Study: NCT00816361
Study Brief: A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. 10 None 4 14 13 14 View
MEDI-573 10 mg/Kg QWk Dose Escalation Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. 3 None 1 3 3 3 View
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. 9 None 6 13 13 13 View
MEDI-573 30 mg/Kg Q3Wk Dose Escalation Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. 1 None 0 3 3 3 View
MEDI-573 45 mg/Kg Q3Wk Dose Escalation Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. 3 None 3 3 3 3 View
MEDI-573 0.5 mg/Kg QWk Dose Escalation Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. 4 None 2 4 4 4 View
MEDI-573 1.5 mg/Kg QWk Dose Escalation Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. 3 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
Cerumen impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.0 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Faecaloma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Glossitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Implant site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Excoriation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Post procedural discomfort SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood growth hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood insulin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Cardiac enzymes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Electrocardiogram qt prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Protein total increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 15.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
Scrotal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View
Systolic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View