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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
NCT ID:
NCT02669667
Description:
None
Frequency Threshold:
0
Time Frame:
From the start of study drug administration upto Day 240
Study:
NCT02669667
Study Brief:
Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. | 0 | None | 0 | 12 | 8 | 12 | View |
| Cohort 1 | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | 0 | None | 0 | 4 | 4 | 4 | View |
| Cohort 2 | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | 0 | None | 0 | 4 | 2 | 4 | View |
| Cohort 5 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 3 | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | 0 | None | 0 | 6 | 5 | 6 | View |
| Cohort 4 | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | 0 | None | 0 | 6 | 4 | 6 | View |
| Cohort 6 | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. | 0 | None | 0 | 6 | 5 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Skin bacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Scratch | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Myalgia intercostal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Miliaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Infusion site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 20.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Infusion site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Infusion site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site bruising | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site induration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Injection site warmth | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |