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 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:06 PM
NCT ID:
NCT02849457
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events occurring from enrollment through a patient's 36 month age visit (an average study duration of approximately 34 months). Note, patients could enroll at different ages, but had a common final study visit corresponding to age 36 months. Adverse events were assessed/collected at every study visit, and serious adverse events were collected in real time and reported to the medical safety monitor for the study.
Study:
NCT02849457
Study Brief:
Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Delayed Vigabatrin (Placebo), Pre-randomization | Patients who were eventually randomized to the Delayed Vigabatrin (Placebo) arm. The adverse events reflected in this arm occurred prior to randomization and initiation of study drug. | 0 | None | 3 | 27 | 4 | 27 | View |
| Early Vigabatrin, Pre-randomization | Patients who were eventually randomized to the Early Vigabatrin arm. The adverse events reflected in this arm occurred prior to randomization and initiation of study drug. | 0 | None | 2 | 29 | 4 | 29 | View |
| Delayed Vigabatrin (Placebo), Post-randomization | Study drug (in this case, placebo) is given for administration, the entire content of one sachet (500 mg placebo) is dissolved in 10 ml water for oral administration that is dosed according to body weight 50-150 mg/kg/day divided BID. Dosing will follow established recommended guidelines (50 mg/kg/day and increased as needed by 50 mg/kg/day every 3 days up to a maximum dose of 150 mg/kg/day, divided BID). Participants randomized to this arm will be treated with matching placebo until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on placebo, they will be eligible for Open label vigabatrin. Participants will be followed until 36 months of age. | 0 | None | 14 | 27 | 15 | 27 | View |
| Early Post-randomization | Study drug (in this case, vigabatrin) is given for administration, the entire content of one sachet (500 mg vigabatrin) is dissolved in 10 ml water for oral administration that is dosed according to body weight 50-150 mg/kg/day divided BID. Dosing will follow established recommended guidelines (50 mg/kg/day and increased as needed by 50 mg/kg/day every 3 days up to a maximum dose of 150 mg/kg/day, divided BID). Participants randomized to this arm will be treated with vigabatrin until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on vigabatrin, they will be eligible for Open label vigabatrin. Participants will be followed until 36 months of age. | 0 | None | 15 | 29 | 17 | 29 | View |
| Watchful Waiting (Open Label Vigabatrin), Before Use of Vigabatrin | Participants in this group eventually had a seizure and were placed on open label vigabatrin; however, the adverse events in this arm occurred prior to beginning open label vigabatrin. | 0 | None | 2 | 4 | 3 | 4 | View |
| Watchful Waiting (Open Label Vigabatrin), After Starting Vigabatrin | Participants in this group experienced seizures prior to detection of EEG epileptiform activity and where immediately placed on open label Vigabatrin. The adverse events in this arm occurred after beginning open label vigabatrin. | 0 | None | 2 | 4 | 3 | 4 | View |
| Watchful Waiting (Control Group) | Enrolled participants in this arm are those who never develop EEG abnormalities or clinical seizures during the length of the study. While all participants who enrolled in the study started in this group, participants were randomized upon development of EEG epileptiform activity. All participants who completed the study without developing EEG epileptiform activity or clinical seizures are reported in this group. | 0 | None | 1 | 12 | 7 | 12 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Congenital, familial and genetic disorders | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Immune system disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Ear and labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |