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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT02640612
Description: An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. SAF was used for AE assessment.
Frequency Threshold: 5
Time Frame: From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.
Study: NCT02640612
Study Brief: Long-term Assessment of Safety and Efficacy of BI 695501 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
BI 695501 to BI 695501 Patients initially randomized to BI 695501 in Period 1 and re-randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 milligram (mg)/0.8 millilitre (mL) BI 695501 in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by subcutaneous (SC) injection every 2 weeks from Day 1 to Week 48. 1 None 14 225 9 225 View
Humira® to Humira® Patients initially randomized to Humira® in Period 1 and re-randomized to Humira® in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL Humira® in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48. 0 None 8 103 6 103 View
Humira® to BI 695501 Patients initially randomized to Humira® in Period 1 and re- randomized to BI 695501 in Period 2 of the 1297.2 trial. Each patient received 40 mg/0.8 mL Humira® in period 1 and 40 mg/0.8 mL BI 695501 in period 2. The respective treatment was administered by SC injection every 2 weeks from Day 1 to Week 48. 0 None 4 102 2 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 15.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 15.0 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 15.0 View
Incarcerated inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 15.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 15.0 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 15.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders 15.0 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders 15.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 15.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 15.0 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 15.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 15.0 View
Benign soft tissue neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 15.0 View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 15.0 View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 15.0 View
Uterine polyp SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders 15.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 15.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 15.0 View
Henoch-Schonlein purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 15.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders 15.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 15.0 View