Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT01007032
Description: All participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: None
Study: NCT01007032
Study Brief: A Study of IMC-A12 in 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
Cixutumumab Cohort 1 6 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle). None None 1 4 4 4 View
Cixutumumab Cohort 2 10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle). None None 5 7 6 7 View
Cixutumumab Cohort 3 15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle). None None 1 3 3 3 View
Cixutumumab Cohort 4 20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle). None None 0 7 6 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Movement disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Inner ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Injection site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Glycosylated haemoglobin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Onychalgia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View