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 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
NCT ID:
NCT02016560
Description:
None
Frequency Threshold:
0.5
Time Frame:
Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Study:
NCT02016560
Study Brief:
Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Exploratory MCI Subjects | Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24 | 0 | None | 1 | 98 | 21 | 98 | View |
| Exploratory Younger Cognitively Healthy Subjects | Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29 | 0 | None | 0 | 16 | 3 | 16 | View |
| Exploratory Older Cognitively Healthy Subjects | Male or female subjects ≥50 years of age with MMSE ≥29 | 0 | None | 0 | 58 | 17 | 58 | View |
| Exploratory AD Subjects | Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE \>10 | 0 | None | 0 | 51 | 13 | 51 | View |
| Confirmatory Subjects MCI | Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 | 0 | None | 0 | 98 | 13 | 98 | View |
| Confirmatory Subjects AD | Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27 | 0 | None | 0 | 62 | 0 | 62 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Frequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (20.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Injection site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Application site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Application site laceration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Feeling abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Therapeutic response unexpected | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (20.0) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Blood pressure systolic increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (20.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (20.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Head discomfort | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (20.0) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (20.0) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (20.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (20.0) | View |
| Supraventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (20.0) | View |
| Cyanopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (20.0) | View |
| Panic attack | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |