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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT00766506
Description:
None
Frequency Threshold:
0
Time Frame:
From the time a signed informed consent form was obtained until the participant was discharged from ward care
Study:
NCT00766506
Study Brief:
An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fentanyl IONSYS | Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. | None | None | 1 | 58 | 40 | 58 | View |
| Morphine IV PCA | Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours. | None | None | 2 | 50 | 38 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 11.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 11.0 | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 11.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 11.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Faeces discoloured | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Reflux gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 11.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Application site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Application site vesicles | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Catheter Site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Inflammation of wound | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 11.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Lower respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 11.0 | View |
| Wound secretion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Procedural hypotension | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Bladder injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 11.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 11.0 | View |
| Electrocardiogram abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 11.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 11.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Joint effusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Syncope vasovagal | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 11.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Hallucination | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 11.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 11.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 11.0 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA version 11.0 | View |
| Respiratory depression | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Nasal discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | View |
| Drug eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | View |
| Perioperative analgesia | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 11.0 | View |
| Spinal anaesthesia | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 11.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Orthostatic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |
| Wound haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 11.0 | View |