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 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
NCT ID:
NCT00350103
Description:
Adverse Events refer to the Safety Set, consisting of all randomized subjects who took at least one dose of study medication. It was pre-specified in the Statistical Analysis Plan that AEs will be summarized and disclosed for placebo and LCM 400 mg/day (pooled) for all participants, who took at least one dose of medication (Safety Set). AEs were planned to be collected and summarized irrespective of dosing strategy.
Frequency Threshold:
5
Time Frame:
Adverse events were collected from baseline until the end of the trial (up to Week 18)
Study:
NCT00350103
Study Brief:
A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
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 | Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase. | 0 | None | 14 | 179 | 21 | 179 | View |
| Lacosamide Pooled FT and ST | Subjects received LCM as Fast Titration (FT) or Standard Titration (ST). | 0 | None | 28 | 370 | 82 | 370 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bundle branch block left | None | Cardiac disorders | MedDRA 9.1 | View |
| Respiratory tract infection viral | None | Infections and infestations | MedDRA 9.1 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 9.1 | View |
| Appendicitis | None | Infections and infestations | MedDRA 9.1 | View |
| Orchitis | None | Infections and infestations | MedDRA 9.1 | View |
| Diabetic foot | None | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Diabetic ketoacidosis | None | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Diabetes mellitus | None | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA 9.1 | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Toe deformity | None | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Spinal column stenosis | None | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | View |
| Gastrinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | View |
| Cerebrovascular accident | None | Nervous system disorders | MedDRA 9.1 | View |
| Vertebrobasilar insufficiency | None | Nervous system disorders | MedDRA | View |
| Cerebellar syndrome | None | Nervous system disorders | MedDRA | View |
| Ischaemic stroke | None | Nervous system disorders | MedDRA | View |
| Presyncope | None | Nervous system disorders | MedDRA | View |
| Sciatica | None | Nervous system disorders | MedDRA | View |
| Renal colic | None | Renal and urinary disorders | MedDRA | View |
| Metrorrhagia | None | Reproductive system and breast disorders | MedDRA | View |
| Vaginal haemorrhage | None | Reproductive system and breast disorders | MedDRA | View |
| Interstitial lung disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Atrial flutter | None | Cardiac disorders | MedDRA 9.1 | View |
| Atrial fibrillation | None | Cardiac disorders | MedDRA 9.1 | View |
| Acute myocardial infarction | None | Cardiac disorders | MedDRA 9.1 | View |
| Diabetic retinopathy | None | Eye disorders | MedDRA 9.1 | View |
| Jejunitis | None | Gastrointestinal disorders | MedDRA 9.1 | View |
| Asthenia | None | General disorders | MedDRA 9.1 | View |
| Biliary colic | None | Hepatobiliary disorders | MedDRA 9.1 | View |
| Gangrene | None | Infections and infestations | MedDRA 9.1 | View |
| Upper limb fracture | None | Injury, poisoning and procedural complications | MedDRA 9.1 | View |
| Electrocardiogram PR prolongation | None | Investigations | MedDRA 9.1 | View |
| Neuropathy | None | Nervous system disorders | MedDRA | View |
| Intestinal operation | None | Surgical and medical procedures | MedDRA | View |
| Arterial occlusive disease | None | Vascular disorders | MedDRA | View |
| Peripheral ischaemia | None | Vascular disorders | MedDRA | View |
| Thrombosis | None | Vascular disorders | MedDRA | View |
| Hypertension | None | Vascular disorders | MedDRA | View |
| Peripheral arterial occlusive disease | None | Vascular disorders | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vertigo | None | Ear and labyrinth disorders | MedDRA | View |
| Nausea | None | Gastrointestinal disorders | MedDRA | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA | View |
| Dizziness | None | Nervous system disorders | MedDRA | View |
| Headache | None | Nervous system disorders | MedDRA | View |