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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT01181050
Description: Safety analysis set includes all subjects who received one dose of the investigational product or its comparator
Frequency Threshold: 5
Time Frame: The adverse events were collected from dosing until end of trial (a total of 24 weeks)
Study: NCT01181050
Study Brief: Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
4.0 mg/kg Subjects received a single dose of 4 mg/kg NNC0142-0002 None None 3 41 5 41 View
Placebo Subjects received a single dose of placebo None None 1 22 5 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders medDRA 14.1 View
Pancreatitis chronic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders medDRA 14.1 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders medDRA 14.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders medDRA 14.1 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders medDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations medDRA 14.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations medDRA 14.1 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders medDRA 14.1 View