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 @ 2:15 AM
Ignite Modification Date: 2025-12-26 @ 12:45 AM
NCT ID: NCT04556760
Description: Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment. Three additional arms were created to capture Adverse Events for each treatment within the cohort.
Frequency Threshold: 0
Time Frame: From Screening up to Final/ end of treatment visit (Day 79).
Study: NCT04556760
Study Brief: Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1: Prednisolone 40mg Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956 0 None 0 27 7 27 View
Cohort 2: AZD9567 40mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567 0 None 0 8 2 8 View
Cohort 2: Prednisolone 20mg Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD956 0 None 0 8 5 8 View
Cohort 3: Placebo Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo 0 None 0 9 1 9 View
Cohort 1: AZD9567 72mg Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956 0 None 0 27 4 27 View
Cohort 3: Prednisolone 5mg Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo 0 None 0 9 0 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter site related reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 24.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 24.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 24.0 View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 24.0 View
Administration site phlebitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Catheter site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA version 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View