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 @ 6:26 PM
Ignite Modification Date: 2025-12-25 @ 3:55 PM
NCT ID: NCT00116168
Description: No safety information was available for 5 subjects in the 1.0 mg/kg group due to Hurricane Katrina.
Frequency Threshold: 0
Time Frame: Days 0-84
Study: NCT00116168
Study Brief: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
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-528 0.3 mg None None None 0 6 5 6 View
MEDI-528 1 mg None None None 0 6 4 6 View
MEDI-528 3 mg None None None 0 6 6 6 View
MEDI-528 9 mg None None None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymph node palpable SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Red blood cells urine positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Cartilage injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Blood chloride increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Breast tenderness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9.0 View
Haematospermia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9.0 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View