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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
NCT ID:
NCT03418493
Description:
All randomized participants who received study drug.
Frequency Threshold:
5
Time Frame:
Up To 1 Year
Study:
NCT03418493
Study Brief:
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo - Part A | Participants received single IV doses of Placebo. | 0 | None | 0 | 11 | 5 | 11 | View |
| 3 mg LY3316531 IV - Part A | Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV). | 0 | None | 0 | 3 | 1 | 3 | View |
| 15 mg LY3316531 IV - Part A | Participants received single doses of 15 mg LY3316531 administered IV. | 0 | None | 0 | 3 | 1 | 3 | View |
| 300 mg LY3316531 IV - Part A | Participants received single doses of 300 mg LY3316531 administered IV. | 0 | None | 0 | 6 | 1 | 6 | View |
| 300 mg LY3316531 SC- Part A | Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC). | 0 | None | 0 | 6 | 5 | 6 | View |
| 900 mg LY3316531 IV - Part A | Participants received single doses of 900 mg LY3316531 administered IV. | 0 | None | 0 | 6 | 2 | 6 | View |
| 2000 mg LY3316531 IV - Part A | Participants received single doses of 2000 mg LY3316531 administered IV. | 0 | None | 0 | 6 | 1 | 6 | View |
| Placebo - Part B | Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks). | 0 | None | 0 | 2 | 1 | 2 | View |
| 2000 mg LY3316531 IV - Part B | Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks). | 0 | None | 1 | 6 | 4 | 6 | View |
| 300 mg LY3316531 IV - Part C | Participants with psoriasis received single doses of 300 mg LY3316531 administered IV. | 0 | None | 0 | 8 | 7 | 8 | View |
| 75 mg LY3316531 IV - Part A | Participants received single doses of 75 mg LY3316531 administered IV. | 0 | None | 0 | 6 | 1 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chapped lips | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.1 | View |
| Catheter site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Allergy to arthropod sting | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Maternal exposure before pregnancy | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Pregnancy test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.1 | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Temporomandibular joint syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.1 | View |
| Infusion site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.1 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | View |