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 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
NCT ID: NCT01955733
Description: AEs are presented for the Safety Randomised Analysis Set (SAF) which consisted of all randomised subjects who received at least one dose of trial medication in this extension study \[1301.4\].
Frequency Threshold: 5
Time Frame: TEAEs were collected from the first dose of study medication in this extension study [1301.4] and prior to the last date of study medication + 6 months [180 days].
Study: NCT01955733
Study Brief: Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active 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
MabThera From 1301.1 The MabThera from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later. None None 2 29 9 29 View
BI 695500 The subjects were administered BI 695500, concentrate for solution for infusion, 10 mg/mL by intravenous infusion. Two 1000 mg infusions were separated by 2 weeks. Each patient was treated with BI 695500 on Days 1 and 15, with a possible further two infusions at Weeks 24 and 26 for eligible responders. None None 0 30 7 30 View
Rituxan From 1301.1 The Rituxan from 1301.1 recommended dose for use in patients with Rheumatoid Arthritis is 1000 mg by IV infusion followed by a second 1000 mg IV infusion 2 weeks later. None None 2 29 8 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Cerebral microangiopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View