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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:01 AM
NCT ID: NCT02019602
Description: None
Frequency Threshold: 5
Time Frame: Adverse Events were collected during the whole study period (from Week 0 up to Week 25)
Study: NCT02019602
Study Brief: A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SS-M This arm consisted of all participating mothers who entered the screening period and received at least 1 dose of Certolizumab Pegol (CZP) less than or equal to 35 days prior to delivery. 0 None 7 21 3 21 View
SS-I This arm consisted of all infants born to mothers in the SS-M group. 0 None 2 16 4 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Meconium in amniotic fluid NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Arrested labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Gestational diabetes NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Placental insufficiency NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Polyhydramnios NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Prolonged labour NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Macrosomia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA18.1 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA18.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA18.1 View
Perineal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA18.1 View
Vaginal laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA18.1 View
Premature baby NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rheumatoid arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA18.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA18.1 View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA18.1 View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA18.1 View
Foetal hypokinesia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Umbilical cord around neck NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA18.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA18.1 View