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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT01209702
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01209702
Study Brief: A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1: Placebo Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase. None None 0 51 1 51 View
Part 1: Tocilizumab Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase. None None 2 51 3 51 View
Part 2: Placebo Participants received intravenous infusions of placebo once every 4 weeks. AEs reported only until participants escaped or switched to tocilizumab. None None 0 51 1 51 View
All Tocilizumab Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2. This group includes participants randomized to placebo who switched or escaped to tocilizumab treatment for whom adverse events are reported after the start of treatment with tocilizumab. None None 11 260 8 260 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Duodenal ulcer perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Ankylosing spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Bursitis infective staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View