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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:11 AM
NCT ID: NCT00163020
Description: Assessments were both Systematic \& Non-systematic: standard questionnaire, regular investigator assessment, regular laboratory testing, systematic evaluation of medical record, self-reporting by participants, occasional assessment/testing
Frequency Threshold: 5
Time Frame: Adverse events were collected during the 4.9 years the trial was actively enrolling subjects. For each randomized participant, adverse events were captured from randomization until the participant and her baby were discharged from the hospital.
Study: NCT00163020
Study Brief: 17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Group (170HP) Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first. None None 69 216 40 216 View
Control (Castor Oil) Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first. None None 34 105 18 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe Pre-eclampsia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Uterine Atony NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Maternal Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Retained Products of Conception NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Acute Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Maternal Anemia SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Bladder Trauma SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Neonatal Bowel Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neonatal Cardiac Abnormalities SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Maternal Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Maternal Chorioamnionities necessitating preterm delivery SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Neonatal Chronic Lung Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neonatal Congenital Hypospadium SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Congenital Abnormality SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Neonatal Cranial Synostosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Deep Vein Thrombosis (DVT) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Endometritis SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Neonatal Gastroschisis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neonatal Intraventricular Hemorrhage (Stage III or IV) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Maternal HELLP Syndrome SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Neonatal Hypoplastic Lung SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intrauterine Fetal Demise (IUFD) SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Miscarriage SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Neonatal Necrotizing Enterocolitis (NEC) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-Occulusive Thrombus SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripartum Cardiomyopathy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Neonatal Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neonatal Pneumothorax SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Neonatal Post Hemorrhagic Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neonatal Peripheral Pulmonary Stenosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Prolonged Hospitalization - Maternal Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Maternal Pyelonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Maternal Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Neonatal Readmissions to the hospital NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neonatal Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Maternal Supraventricular Tachycardia (SVT) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Maternal Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Maternal Wound Eviceration post Cesarean Section NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nectrotizing Enterocolitis (NEC) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neonatal Meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Inguinal Hernia requiring surgical repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Postpartum Hemorrhage requiring blood transfusion SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gestational Diabetes NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pre-eclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View