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 @ 5:36 PM
Ignite Modification Date: 2025-12-25 @ 3:07 PM
NCT ID: NCT00404768
Description: Safety Population was used for adverse events assessment.
Frequency Threshold: 5
Time Frame: Up to Follow-up (Week 12)
Study: NCT00404768
Study Brief: The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part C: Placebo Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. 0 None 2 34 14 34 View
Part C: Active (GSK221149A) Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. 0 None 2 30 10 30 View
Part A/B: IV GSK221149A Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. 0 None 1 20 12 20 View
Part A/B: Oral GSK221149A Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. 0 None 0 9 3 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Retained placenta or membranes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Amniotic fluid volume decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypoglycaemia neonatal SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperbilirubinaemia neonatal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Meconium in amniotic fluid SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neonatal tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cerebral atrophy congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Heart disease congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Jaundice neonatal SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Postpartum haemorrhage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Neonatal respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Labour pain SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Hyperbilirubinaemia neonatal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Premature rupture of membranes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Anaemia neonatal SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Anaemia of pregnancy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Jaundice neonatal SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Polyhydramnios SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Postpartum depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Infusion site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Macrocephaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Neonatal pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Proteus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Renal impairment neonatal SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Transient tachypnoea of the newborn SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Ureteral disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract infection neonatal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Developmental delay SYSTEMATIC_ASSESSMENT General disorders MedDRA View