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 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
NCT ID:
NCT01775904
Description:
None
Frequency Threshold:
3
Time Frame:
None
Study:
NCT01775904
Study Brief:
A Study of Two Dosage Forms of LY2886721 in Healthy Participants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| LY2886721 ODT (no Water, Fasting) | A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. | None | None | 0 | 26 | 8 | 26 | View |
| LY2886721 ODT (Water, Fed) | A single oral dose of 70 mg LY2886721 in an ODT given with water and after a high-fat breakfast in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. | None | None | 0 | 25 | 6 | 25 | View |
| LY2886721 ODT (Water, Fasting) | A single oral dose of 70 mg LY2886721 in an ODT given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. | None | None | 0 | 24 | 7 | 24 | View |
| LY2886721 Capsule (Water, Fasting) | A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Participants received a dose on the morning of Day 1 in each period. Participants were discharged on Day 5 of each period after study assessment. There was a washout period of at least 7 days between dosing in consecutive periods. | None | None | 0 | 26 | 9 | 26 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Application site discolouration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Application site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Application site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Vessel puncture site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Scoliosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Lip swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |