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 @ 5:13 PM
Ignite Modification Date:
2025-12-25 @ 2:51 PM
NCT ID:
NCT02925650
Description:
None
Frequency Threshold:
0
Time Frame:
From Randomization through Study Day 25.
Study:
NCT02925650
Study Brief:
Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Low Dose | The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule | 0 | None | 0 | 5 | 5 | 5 | View |
| Medium Dose | The study drug Posiphen dosage of 120mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule | 0 | None | 0 | 5 | 4 | 5 | View |
| High Dose | The study drug Posiphen dosage of 180mg is to be taken orally in divided doses, three times per day for a total 23-25 days. Posiphen: oral solid dosage form capsule | 0 | None | 0 | 1 | 0 | 1 | View |
| Placebo | The Placebo comparator is to be taken orally in divided doses, three times per day for a total 23-25 days. Placebo: oral solid dosage form capsule | 0 | None | 0 | 7 | 4 | 7 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.00 | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.00 | View |
| injection site swelling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.00 | View |
| medical device complication | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.00 | View |
| nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.00 | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.00 | View |
| neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | View |
| pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.00 | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | View |
| pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | View |
| paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.00 | View |
| post lumbar puncture syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.00 | View |
| productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.00 | View |
| rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.00 | View |
| sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.00 | View |
| traumatic lumbar puncture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.00 | View |
| tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.00 | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 18.00 | View |
| agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 18.00 | View |
| catheter site swelling | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.00 | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 18.00 | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 18.00 | View |
| injection site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 18.00 | View |
| lethargy | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 18.00 | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | View |
| musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 18.00 | View |