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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT01991860
Description: None
Frequency Threshold: 5.0
Time Frame: 7 days
Study: NCT01991860
Study Brief: US Phase III Study of APD421 in PONV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia 0 None 9 166 160 166 View
APD421 5mg Dose A 5mg dose of APD421 given by slow push, single intravenous (IV) administration over a time frame of one minute at induction of anaesthesia 0 None 8 176 169 176 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Small Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Anaemia Postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.1 View
Post Procedural Constipation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.1 View
Post Operative Ileus NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.1 View
Acute Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 16.1 View
Supraventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 16.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 16.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 16.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 16.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia Postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.1 View
Procedural Pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 16.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 16.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 16.1 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 16.1 View
Hypoproteinaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 16.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 16.1 View
Bood Prolactin Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 16.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 16.1 View