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 @ 9:36 PM
Ignite Modification Date: 2025-12-25 @ 7:20 PM
NCT ID: NCT00724932
Description: The AST Population consisted of all randomized participants who received IMP. * Serious Adverse Events (SAEs) include both pre-treatment (from signing of informed consent to start of IMP administration) and post-treatment (from start of IMP administration to 7 days after IMP administration) SAEs.
Frequency Threshold: 5
Time Frame: Up to 7 days after IMP administration
Study: NCT00724932
Study Brief: Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sugammadex Participants receiving 4.0 mg.kg-1 sugammadex at 1-2 PTC None None 5 66 64 66 View
Neostigmine Participants receiving 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine: atropine) at reappearance of T2 None None 6 67 63 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis None Gastrointestinal disorders MedDRA 12.1 View
Pancreatitis acute None Gastrointestinal disorders MedDRA 12.1 View
Operative haemorrhage None Injury, poisoning and procedural complications MedDRA 12.1 View
Post procedural complication None Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural nausea None Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural pain None Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural vomiting None Injury, poisoning and procedural complications MedDRA 12.1 View
Muscle rigidity None Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Sedation None Nervous system disorders MedDRA 12.1 View
Vascular calcification None Vascular disorders MedDRA 12.1 View
Vascular thrombosis limb None Vascular disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain None Gastrointestinal disorders MedDRA 12.1 View
Constipation None Gastrointestinal disorders MedDRA 12.1 View
Dry mouth None Gastrointestinal disorders MedDRA 12.1 View
Flatulence None Gastrointestinal disorders MedDRA 12.1 View
Nausea None Gastrointestinal disorders MedDRA 12.1 View
Vomiting None Gastrointestinal disorders MedDRA 12.1 View
Anaesthetic complication cardiac None Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural nausea None Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural pain None Injury, poisoning and procedural complications MedDRA 12.1 View
Procedural vomiting None Injury, poisoning and procedural complications MedDRA 12.1 View
C-reactive protein increased None Investigations MedDRA 12.1 View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders MedDRA 12.1 View