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 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
NCT ID:
NCT01756833
Description:
Adverse Events were classified without regard to specific Adverse Event Term.
Frequency Threshold:
0
Time Frame:
Two years
Study:
NCT01756833
Study Brief:
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
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 | 100 mg capsules, twice a day, for a period of two years. Placebo: capsule identical to the doxycycline capsule | 4 | None | 71 | 125 | 111 | 125 | View |
| Doxycycline | 100 mg capsules, twice a day, for a period of two years. Doxycycline: 100 mg po bid | 3 | None | 70 | 129 | 121 | 129 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Serious or Unexpected Adverse Events | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (10.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Frequent joint pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Frequent gastric or intestinal upset | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (10.0) | View |
| Frequent bleeding or bruising | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (10.0) | View |
| Frequent spells of dizziness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Skin rash or hives | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Visual disturbance | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (10.0) | View |
| Moderate to severe sunburn | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (10.0) | View |
| Frequent headaches | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Tooth discoloration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |
| Other symptom requiring study drug dose adjustment or discontinuation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (10.0) | View |