Adverse Events Module

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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 @ 2:04 AM
Ignite Modification Date: 2025-12-26 @ 12:29 AM
NCT ID: NCT02255760
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
Study: NCT02255760
Study Brief: Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
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 dose of placebo by IV infusion up to a maximum of 12 hours. 0 None 0 14 4 14 View
MEDI3902 - Dose 1 Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. 0 None 0 3 2 3 View
MEDI3902 - Dose 2 Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. 0 None 0 15 6 15 View
MEDI3902 - Dose 3 Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. 0 None 0 15 8 15 View
MEDI3902 - Dose 4 Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. 0 None 0 9 6 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Periorbital contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.0 View