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 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
NCT ID:
NCT02167256
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events data were collected over a period of 1 year (study duration)
Study:
NCT02167256
Study Brief:
A Phase IIa Multi-Center Study of 18F-FDG PET, Safety, and Tolerability of AZD0530 in Mild 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 |
|---|---|---|---|---|---|---|---|---|
| AZD0530 100mg/125mg Daily | AZD0530 100mg daily: All patients in experimental group (50%) were started on 100mg AZD0530 daily AZD0530 125mg daily: Patients with plasma drug level \<100ng/ml after 2 weeks of 100mg AZD0530 daily received 125mg daily of AZD0530. | 1 | None | 12 | 79 | 73 | 79 | View |
| AZD0530 Placebo | Placebo: 50% of patients will receive placebo treatment for the duration of the study. | 0 | None | 7 | 80 | 65 | 80 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Metabolism and nutrition disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| General disorders and administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Eye disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Blood and lymphatic system disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Ear and labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Reproductive system and breast disorders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Immune system disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Endocrine disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Vascular disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Musculoskeletal and connective tissue disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Psychiatric disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |