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 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
NCT ID:
NCT02206620
Description:
Adverse Events were systematically collected by phone call every week. Study clinicians recorded adverse events and reported to the IRB unexpected or serious adverse events. An independent neurologist reviewed the reported adverse events each six months and made recommendations to the trial leadership as well as the IRB about advisability of continuation of the trial.
The adverse events are reported below per intervention for each Arm/Group of the study.
Frequency Threshold:
5
Time Frame:
Adverse Events were collected through study completion, an average of 18 weeks.
Study:
NCT02206620
Study Brief:
Effects of Cholinergic Augmentation on Measures of Balance and Gait
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Donepezil, Then Placebo (Phase I) | Participants took a donepezil 5mg tablet each day for 3 weeks, then increased the dose to 10mg (2 tablets each day) for 3 weeks. (This was followed by 6 weeks of a washout period and then taking the placebo in the same format -- 3 weeks of one tablet, followed by 3 weeks of 2 tablets to replicate the dosage increase.) | 0 | None | 0 | 22 | 18 | 22 | View |
| Placebo, Then Donepezil (Phase I) | Participants took the placebo at one tablet each day for 3 weeks, then increased the dosage to 2 tablets each day for 3 weeks. (This was followed by 6 weeks of a washout period and then taking donepezil in the same format -- donepezil 5mg tablet each day for 3 weeks, followed by 3 weeks of an increased dose of 10mg (2 tablets each day).) | 0 | None | 0 | 27 | 18 | 27 | View |
| Donepezil, Then Placebo (Washout) | There were 6 weeks of a washout period after participants had taken donepezil for 6 weeks. | 0 | None | 0 | 21 | 5 | 21 | View |
| Placebo, Then Donepezil (Washout) | There were 6 weeks of a washout period after participants had taken the placebo for 6 weeks. | 0 | None | 1 | 26 | 8 | 26 | View |
| Donepezil, Then Placebo (Phase II) | After the washout period, participants took the placebo in the same format as the donepezil -- 3 weeks of one tablet, followed by 3 weeks of 2 tablets to replicate the dosage increase. | 0 | None | 0 | 21 | 4 | 21 | View |
| Placebo, Then Donepezil (Phase II) | Then participants took donepezil in the same formats the placebo -- the donepezil 5mg tablet each day for 3 weeks, followed by 3 weeks of an increased dose of 10mg (2 tablets each day). | 0 | None | 0 | 26 | 26 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pulmonary Embolus | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hallucinations | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Memory Disturbances | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Increased Saliva | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Decreased Saliva | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Urinary Frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Vivid Dreams | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Light Headedness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle Cramps | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |