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 @ 3:32 PM
Ignite Modification Date: 2025-12-25 @ 1:46 PM
NCT ID: NCT02750592
Description: All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
Frequency Threshold: 5
Time Frame: AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 60 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 60 weeks
Study: NCT02750592
Study Brief: Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AIN457 150mg A screening (SCR) epoch ran 4-10 weeks before baseline (BSL) and was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consisted of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 there was a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinued prematurely. 0 None 3 30 26 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (21.0) View
Adenocarcinoma of the cervix SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.0) View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Infected dermal cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View