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 @ 1:58 PM
Ignite Modification Date:
2025-12-25 @ 12:45 PM
NCT ID:
NCT01138995
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Study:
NCT01138995
Study Brief:
Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Originial Control Group | The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks. | None | None | 7 | 98 | 61 | 98 | View |
| Original Treatment Group | The Original Treatment Group will walk with the Ness L300 for 30 weeks. The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke. | None | None | 15 | 99 | 82 | 99 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| stroke/high blood pressure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| cholecystectomy | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| pneumonia/respiratory | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| cancer | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Bone fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| kidney damage due to dehydration | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| anemia requiring blood transfusion | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| ovarian mass | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| bowel obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| methicillin resistant Staphylococcus aureus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| mental depression and anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| hospitalization general complaints | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| localized skin redness, rash, irritation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Eye irritation and hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| seasonal allergies | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| hypertonia, headache, dizziness, memory deficit | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Nausea or abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hypertension and/or flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| joint pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Fear or depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| gout or diabetes | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Atrial fibrillation or abnormal heartbeat | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| asthma, cough, bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| renal mass | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| blister, folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| fall with or without injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |