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 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
NCT ID:
NCT04524351
Description:
None
Frequency Threshold:
0
Time Frame:
25±2 days
Study:
NCT04524351
Study Brief:
Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Posiphen, 80mg (Parkinson's Participants) | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. Posiphen: Solid oral dosage form, capsule | 0 | None | 0 | 10 | 3 | 10 | View |
| Posiphen, 40mg (Parkinson's Participants) | Posiphen Oral Capsule, 40mg, taken once per day for 25±2 days. Posiphen: Solid oral dosage form, capsule | 0 | None | 0 | 10 | 5 | 10 | View |
| Posiphen, 20mg (Parkinson's Participants) | Posiphen Oral Capsule, 20mg, taken once per day for 25±2 days. Posiphen: Solid oral dosage form, capsule | 0 | None | 0 | 11 | 4 | 11 | View |
| Posiphen, 10mg (Parkinson's Participants) | Posiphen Oral Capsule, 10mg, taken once per day for 25±2 days. Posiphen: Solid oral dosage form, capsule | 0 | None | 0 | 10 | 6 | 10 | View |
| Placebo (Alzheimer's Participants) | Placebo Oral Capsule, taken once per day for 25±2 days. Placebo: Solid oral dosage form, capsule | 0 | None | 0 | 6 | 3 | 6 | View |
| Posiphen, 5mg (Parkinson's Participants) | Posiphen Oral Capsule, 5mg, taken once per day for 25±2 days. Posiphen: Solid oral dosage form, capsule | 0 | None | 0 | 12 | 1 | 12 | View |
| Placebo (Parkinson's Participants) | Placebo Oral Capsule, taken once per day for 25±2 days. Placebo: Solid oral dosage form, capsule | 0 | None | 0 | 5 | 3 | 5 | View |
| Posiphen, 80mg (Alzheimer's Participants) | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. Posiphen: Solid oral dosage form, capsule | 0 | None | 0 | 10 | 5 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| electrocardiogram QT prolongation | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| post lumbar puncture syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| catheter site paraesthesia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| procedural headache | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| uppper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| urine analysis abnormal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| movement disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |