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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT00462904
Description: study suspended
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT00462904
Study Brief: Pharmacokinetic Response to BPI in Burns
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BPI Infusion Group BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours BPI: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours 0 None 1 4 4 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PAIN NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ACIDOSIS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
AGGITATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ALKALOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
AZOTEMIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CELLULITIS/ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations None View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DECREASED PRE-ALBUMIN NON_SYSTEMATIC_ASSESSMENT Investigations None View
FEVER SYSTEMATIC_ASSESSMENT General disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HYPERCHLORIDEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERMAGNESEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERNATREMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERPHOSPHATEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPOALBUMINEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPOCALCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ileus, GI SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased C-Reactive Protein SYSTEMATIC_ASSESSMENT Investigations None View
Increased CRP SYSTEMATIC_ASSESSMENT Investigations None View
Infection Bladder SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection Skin SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection Skin Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oversedation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain NON_SYSTEMATIC_ASSESSMENT Investigations None View
Polycythemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vol Overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View