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 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
NCT ID:
NCT01419769
Description:
Events are categorized as Post-index Procedure, Early Post-Stent Removal (within 7 days of stent removal), and Late Post-Stent Removal (beyond 7 days)
Frequency Threshold:
0
Time Frame:
From index procedure up to 6 months post-stent removal
Study:
NCT01419769
Study Brief:
AXIOS Stent & Delivery System Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| AXIOS Stent and Delivery System | AXIOS Stent \& Delivery System: The AXIOS Stent \& Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States. Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates. Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal. | None | None | 16 | 33 | 15 | 33 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain and nausea after eating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain and vomiting after eating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain, nausea, and vomiting after eating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal pain and syncope, GI bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| GI Bleed | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache and lightheadedness/ dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Left shoulder/ back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Severe dehydration | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Mucus overgrowth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea and vomiting only after eating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain and pressure, shortness of breath, heart palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Intraperitoneal air | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea after eating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Vomiting after eating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lightheadedness/ dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| New pancreatic pseudocyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Black stool | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bleeding | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| J-tube clogged | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pancreatic cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Pancreatic duct obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Peripancreatic inflammation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |