Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 4:00 AM
NCT ID: NCT02248818
Description: From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
Frequency Threshold: 1
Time Frame: SAD cohorts 2 weeks, MAD cohorts up to 1 month
Study: NCT02248818
Study Brief: AZD8108 SAD/MAD in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD8108 90 mg MAD (6) AZD8108 90 mg MAD, Cohort 6 None None 0 8 1 8 View
AZD8108 20 mg SAD AZD8108 20 mg SAD, Cohort 1 None None 0 6 6 6 View
AZD8108 60 mg SAD AZD8106 60 mg SAD, Cohort 2 None None 0 6 4 6 View
AZD8108 95 mg SAD AZD8108 95 mg SAD, Cohort 3 None None 0 6 4 6 View
Placebo SAD Placebo SAD, pooled across Cohorts 1 - 3 None None 0 6 3 6 View
AZD8108 50 mg MAD AZD8108 50 mg MAD, Cohort 5 None None 0 6 3 6 View
AZD8108 90 mg MAD (7) AZD8108 90 mg MAD, Cohort 7 None None 0 6 4 6 View
Placebo MAD Placebo MAD, pooled across Cohorts 5 \& 7 None None 0 4 3 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 17.1 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 17.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17.1 View
Rash pustular NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 17.1 View
Muscle Twitching NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 17.1 View
Dysguesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17.1 View
Nystagmus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17.1 View
Euphoric mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 17.1 View
Halucination, visual NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 17.1 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 17.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 17.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 17.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 17.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17.1 View
Sensory disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 17.1 View
Dysphoria NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 17.1 View
Initial insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 17.1 View
Nightmare NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 17.1 View
Dermatitis acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 17.1 View