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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT00099359
Description: AE data collected from study entry to off study period
Frequency Threshold: 5
Time Frame: through 6 months
Study: NCT00099359
Study Brief: Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ARM A (ZDV Alone) ZDV, given for 6 weeks: 12 mg PO BID if birthweight (BW) \> 2000 grams 8 mg PO BID if BW \< 2000 grams None None 219 581 492 581 View
ARM B (ZDV + NVP) ZDV, given for 6 weeks: 12 mg PO BID if birthweight (BW) \> 2000 grams 8 mg PO BID if BW \< 2000 grams AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW \> 2000 grams, 8 mg PO per dose if BW \< 2000 grams None None 211 580 482 580 View
ARM C (ZDV + 3TC/NFV) ZDV, given for 6 weeks: 12 mg PO BID if birthweight (BW) \> 2000 grams 8 mg PO BID if BW \< 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW \> 2000 grams 4 mg po bid if BW \< 2000 grams AND NFV, given for 2 weeks: 200 mg po bid if BW \> 3000 grams 150 mg po bid if BW \> 2,000 - 3000 grams 100 mg PO BID if BW \< 2000 grams None None 252 574 480 574 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia Nos SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Axillary Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Disseminated Intravascular Coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Isoimmune Haemolytic Disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Polycythaemia Nos SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Thrombocythaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Cyanosis Nos SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Pulmonary Valve Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Tachycardia Nos SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Tricuspid Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Cardiac Disorder Nos SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Cardiac Failure Nos SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Congenital Atrial Septal Defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Cardiac Septal Defect Nos SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6.0 View
Congenital Choroid Plexus Cyst SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Clubfoot SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Cytomegalovirus Infection SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Infection Nos SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Macrocephaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Syphilis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Toxoplasmosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Congenital Ventricular Septal Defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Foetal Alcohol Syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Genitalia External Ambiguous SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Meningomyelocele SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Patent Ductus Arteriosus SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Retinoblastoma Nos SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Trisomy 21 SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Urethral Valves SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 6.0 View
Neonatal Conjunctivitis Nos SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6.0 View
Acquired Pyloric Stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Diarrhoea Nos SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Gastrooesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Intestinal Obstruction Nos SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Intestinal Perforation Nos SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Vomiting Nos SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6.0 View
Drug Withdrawal Syndrome Neonatal SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Multi-Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Sudden Infant Death Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 6.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6.0 View
Jaundice Nos SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6.0 View
Abscess Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Arthritis Bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Breast Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Bronchitis Acute Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Bronchopneumonia Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Cellulitis Gangrenous SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Conjunctivitis Infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Febrile Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Gastroenteritis Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Gastrointestinal Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Impetigo Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Lobar Pneumonia Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Lower Respiratory Tract Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Mastitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Meningitis Pneumococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Neonatal Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Omphalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Oral Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Otitis Media Acute Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Parainfluenzae Virus Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Periorbital Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Pertussis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Pneumocystis Carinii Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Pneumocystis Carinii Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Pneumonia Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Pulmonary Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Respiratory Syncytial Virus Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Respiratory Tract Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Scabies Infestation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Sepsis Neonatal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Sepsis Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Tuberculosis Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Umbilical Cord Sepsis Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Upper Respiratory Tract Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Urinary Tract Infection Nos SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Clavicle Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6.0 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6.0 View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6.0 View
Hypothermia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6.0 View
Acoustic Stimulation Tests Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Blood Calcium Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Blood Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Blood Potassium Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Blood Urea Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Cardiac Murmur Nos SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
General Physical Condition Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Electrolyte Imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Failure To Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Feeding Problem In Newborn SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
General Nutrition Disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hyperglycaemia Nos SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hypoglycaemia Nos SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Malnutrition Nos SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Marasmus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Metabolic Acidosis Nos SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Underweight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6.0 View
Tongue Neoplasm Nos SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6.0 View
Cerebral Thrombosis Nos SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Convulsions Nos SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Encephalitis Nos SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Poor Sucking Reflex SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Visual Field Defect Nos SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6.0 View
Jaundice Neonatal SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 6.0 View
Premature Baby SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 6.0 View
Small For Dates Baby SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 6.0 View
Renal Failure Nos SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6.0 View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Asphyxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Asthma Nos SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Bronchitis Nos SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Bronchospasm Nos SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Cyanosis Neonatal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Neonatal Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Obstructive Airways Disorder Nos SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Pneumothorax Nos SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Pulmonary Artery Stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Pulmonary Oedema Nos SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6.0 View
Face Oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6.0 View
Urticaria Nos SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6.0 View
Exposure To Communicable Disease SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 6.0 View
Social Problem Nos SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 6.0 View
Cardiac Operation Nos SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 6.0 View
Eye Excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 6.0 View
Hypertension Nos SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6.0 View
Vasculitis Nos SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NOS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6.0 View
oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6.0 View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6.0 View