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 @ 11:29 PM
Ignite Modification Date: 2025-12-25 @ 9:16 PM
NCT ID: NCT00267956
Description: 2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
Frequency Threshold: 5
Time Frame: 36 weeks
Study: NCT00267956
Study Brief: An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic 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
Placebo (CP) Controlled period (Week 0-12) - Placebo Group None None 3 70 19 70 View
Ustekinumab x 4 (CP) Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group None None 0 76 29 76 View
Placebo -> Ustekinumab (After CP) After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -\> receiving ustekinumab at Week 12 and Week 16 None None 4 57 19 57 View
Ustekinumab x 4 (After CP) After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -\> receiving Placebo at Week 12 and Week 16 None None 2 74 24 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View