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: 2025-12-25 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT02543658
Description: The main adverse events observed were the effects of neostigmine on the cardiovascular system, such as arrhythmias and decreased blood pressure
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02543658
Study Brief: Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Neostigmine Intramuscular injection of neostigmine Neostigmine Methylsulfate 1 MG/ML: The initial dose was 1mg intramuscular injection, q12h. If there is no defecation after 12 hours, the dose is increased to 1mg intramuscular injection, Q8H; if there is no defecation after 24 hours, the dose is increased to 1mg intramuscular injection, Q6 H. If the abdominal pressure drops below 12mmhg, stop using the drug, otherwise, it will be used for 7 days. Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage. 10 None 8 40 0 40 View
The Traditional Treatment Conservative treatment recommended by the guidelines, such as maintain the negative balance of fluid after the early recovery of fluid to stabilize the circulation, and to take appropriate sedative and analgesic treatment; negative pressure of the nasogastric tube attracts the contents of the stomach, and the glycerin is enema through the anus to promote defecation.Patients with ascites underwent percutaneous drainage. 11 None 4 40 0 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Single cardiovascular failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular and respiratory failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular and renal failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular, respiratory and renal failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):