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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT02606903
Description: Regular investigator assessment at study visits. The safety analysis set was used which consisted of all subjects who provided informed consent and who received at least one dose of trial medication.
Frequency Threshold: 5
Time Frame: From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period
Study: NCT02606903
Study Brief: Pharmacokinetics and Safety of BI 695501 Administered Via Prefilled Syringe or Autoinjector
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 Autoinjector (AI) Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in auto injector via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Test Product) None None 0 35 28 35 View
BI 695501 Pre-filled Syringe (PFS) Subject received single dose of 40 milligram (mg)/ 0.8 milliliters (mL) BI 695501 solution for injection in pre-filled syringe via subcutaneous injection followed by a 43-day observation period and up to 70 days safety follow-up period. (Reference Product) None None 0 36 23 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View