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: 2025-12-24 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:55 PM
NCT ID: NCT03368235
Description: The Safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.
Frequency Threshold: 5
Time Frame: From first administration of study treatment (Day 1) up to 2 weeks after last administration of study treatment, approximately 28 days.
Study: NCT03368235
Study Brief: Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AZD9567 Participants received AZD9567 40 mg oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks. 0 None 1 11 10 11 View
Prednisolone Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks. 0 None 0 10 9 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.1 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.1 View
Periorbital swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Oral discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.1 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Restless legs syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Mood swings SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Skin atrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View