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 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
NCT ID:
NCT02323334
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT02323334
Study Brief:
A Study of LY3202626 in Healthy Participants and Participants With 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 |
|---|---|---|---|---|---|---|---|---|
| Part A, B, and C Placebo | Single dose of placebo given PO in in capsule form, Part A and B. Multiple doses of placebo given PO in capsule form, Part C. | None | None | 0 | 36 | 10 | 36 | View |
| Part A 0.1mg LY3202626 | Single dose of 0.1mg LY3202626 given PO in in capsule form. | None | None | 0 | 8 | 0 | 8 | View |
| Part A 0.4mg LY3202626 | Single dose of 0.4mg LY3202626 given PO in in capsule form. | None | None | 0 | 8 | 1 | 8 | View |
| Part A 0.4mg LY3202626 + 200mg Itraconazole | Single dose of 0.4mg LY3202626 +200mg Itraconazole given PO in in capsule form. | None | None | 0 | 12 | 7 | 12 | View |
| Part C 1mg LY3202626 QD | Multiple daily dose of 1mg LY3202626 given PO in in capsule form. | None | None | 0 | 9 | 4 | 9 | View |
| Part A and B 1.6mg LY3202626 | Single dose of 1.6mg LY3202626 given PO in in capsule form.. | None | None | 0 | 13 | 4 | 13 | View |
| Part A 5mg LY3202626 | Single dose of 5mg LY3202626 given PO in in capsule form. | None | None | 0 | 8 | 3 | 8 | View |
| Part C and Part D 6mg LY3202626 QD | Multiple daily dose of 6mg LY3202626 given PO in capsule form. | None | None | 0 | 11 | 6 | 11 | View |
| Part A and B 10mg LY3202626 | Single dose of 10mg LY3202626 given PO in capsule form. | None | None | 0 | 19 | 7 | 19 | View |
| Part A 15mg LY3202626 | Single dose of 15mg LY3202626 given PO in capsule form. | None | None | 0 | 11 | 2 | 11 | View |
| Part B and C 26mg LY3202626 | Single dose of 26mg LY3202626 given PO in capsule form, Part B. Multiple daily dose of 26mg LY3202626 in in capsule form, Part C. | None | None | 0 | 14 | 13 | 14 | View |
| Part A 45mg LY3202626 | Single dose of 45mg LY3202626 given PO in in capsule form. | None | None | 0 | 8 | 1 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Postural orthostatic tachycardia syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 17.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 17.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| Post lumbar puncture syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 17.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 17.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | View |
| Burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 17.0 | View |
| Abnormal dreams | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| Nightmare | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 17.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 17.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.0 | View |