TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Change in Dual Task Performance and Functional Magnetic Resonance Imaging (fMRI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in D-KEFS Verbal Fluency Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Tower of London Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Wisconsin Card Sorting Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Snaith-Hamilton Pleasure Scale Score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: medium morphine dose (mg/kg/die)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Composite Gene Expression Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Hamilton Depression Scale (HAMD) Scores
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in Wechsler Memory Scale (WMS) Scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change from Baseline in Box And Block Test (BBT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants With Intravenous Administration
Endpoint domain: Adverse events/effects
Primary endpoint: Long term outcome of Type III-IF patients with short bowel syndrome
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Diagnosis of anatomical and functional causes of stridor and dysphonia
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: modified Rankin Scale (mRS) of 0-2 at 90 days
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: graft vs leukemia effects
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: graft vs tumor effects
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Sensitivity and specificity of DVFE
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Differences between lesional margins identified by COE and DVFE
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prevention of SREs
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Recommended Phase II Dose of Dasatinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Rate of freedom from documented atrial fibrillation, atrial tachycardia, or atrial flutter
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Weight at 4 months post-delivery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Intraprostatic CD8+ T Cell Infiltration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Treatment Failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Short Form 36 (SF-36)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Faces Pain Scale - Revised (FPS-R)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Abdominal Pain Frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Stool Frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of patients with stabilization of visual acuity, vision loss of < 15 letters
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of subjects who gain at least 15 letters in the best corrected visual acuity score at 6 and 12 months compared to baseline
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)
Endpoint domain: Adverse events/effects
Primary endpoint: % Days w/1+Interlock Test Failures
Endpoint domain: Adverse events/effects
Primary endpoint: Myocardial Blood Flow (MBF) assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Endothelial dysfunction assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Safety of Clazakizumab
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Pulse Rate (Supine, After 1 Minute)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Systolic Blood Pressure (Supine, After 1 Minute)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Diastolic Blood Pressure (Supine, After 1 Minute)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Nociceptive blink reflex habituation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Irritable bowel syndrome symptom score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: glycemic control measured by HbA1c
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Changes in total International Prostate Symptom Scores (I-PSS)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of Participants With Grade 1-5 Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Exercise tolerance (total exercise time)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline of Vital signs
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline of biomarkers
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline of other safety parameters after single intravenous and subcutaneous administration
Endpoint domain: Adverse events/effects
Primary endpoint: Asparaginase-Related Toxicity Rate
Endpoint domain: Adverse events/effects
Primary endpoint: thrombotic events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Verbal Memory Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Information processing psychomotor function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Visual Working Memory
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Diagnostic accuracy of breast RSI
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Road traffic accidents cases
Endpoint domain: Adverse events/effects
Primary endpoint: vita sexualis
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of subjects with adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Left Ventricle Mean Diastolic Pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Total:HDL-cholesterol ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: plasma concentration of C-reactive protein
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Recommended Phase II Dose (RP2D) of Ribavirin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AAC for Daily EXACT Scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Abdominal Visceral Fat
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: sPLA2 levels and activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical Improvement in Thigh Circumference
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Predictive accuracy of drug safety score (DSS) in correlating with serious ADRs
Endpoint domain: Adverse events/effects
Primary endpoint: Reactive doses of peanut (mg) at which an allergic reaction appears
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Retina nerve fiber layer measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Macular thickness measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complete fluorescence measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Propofol requirement until loss of consciousness
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: child length at birth
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: child length-for-age Z-score (LAZ) at 18 months of age
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: lung function tests
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: CT scans to measure the thickness of the tubes in the lungs
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: chemical products in the lungs and body that relate to COPD
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with low disease activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Regions responsible for epileptic discharges
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Difference in SUV of the 4 upper ROI's between cemented and uncemented groups
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Difference in SUV of all 9 ROI's between cemented and uncemented acetabular study groups
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 129Xe MRI results
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of acute exacerbation of COPD
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Safety of SCV-07
Endpoint domain: Adverse events/effects
Primary endpoint: Immunomodulatory effects of SCV-07
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: fMRI BOLD signal differences between groups in Stroop task
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Reaction times in Stroop task
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Stop Signal reaction times (SSRT) from Stop Signal Task (SST)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: decreased intensity of pain in referred otalgia
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Diagnostic Ultrasound Exams
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Changes on motor evoked potentials
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: change from baseline in mean pulmonary arterial pressure (MPAP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Quit Attempt(s)
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Psychomotor development at 1.5 years of age
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Elimination of snoring
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Three-year Overall Survival
Endpoint domain: Mortality/survival
Primary endpoint: Hamilton Depression Rating Scale - Grid version
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in skeletal muscle whole muscle membrane fatty acid composition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in skeletal muscle plasma membrane fatty acid composition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in skeletal muscle mitochondrial membrane composition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fibrinogen Level Change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Number of proximal humerus landmarks successfully identified
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: VAS ratings of pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants who died within one year
Endpoint domain: Mortality/survival
Primary endpoint: Number of rehospitalizations due to heart failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of participants with recurrent regurgitation within one year
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Recurrence Rate of Pterygium
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Timed 25-foot Walk Speed
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rabies virus neutralizing antibody (RVNA) levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Depressive rumination
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Repetitive negative thinking (RNT)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in pupillary diameter
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in accommodative amplitude
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peak stress perfusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Eye bags
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Dark circles
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Relaxed features
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Change from baseline in urinary sodium excretion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change in Brief Ataxia Rating Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Number of bacteremia positive patients
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Reduction of Predicted Cardiovascular Risk
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Yale Global Tic Severity Scale total tic score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Increased evoked EMG muscle activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Disabling Post-Traumatic Stress
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: General Skin Appearance of Mons Pubis and Labia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Change in immune function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Model-Based Annualized Bleed Rate (ABR) for Treated Bleeds
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Model-Based Annualized Bleed Rate (ABR) for All Bleeds
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Mean Calculated Annualized Bleed Rate (ABR) for Treated Bleeds
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Gastric cancer status
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: 8-hour cortisol level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Maximum Observed Concentration (Cmax) of Pirtobrutinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in systolic daytime mean ABPM values
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Global Cognition Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Reduction of fluid stool
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Ang 1-7 increase from baseline
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of abnormal and clinically relevant changes in electrocardiogram
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Incidence of abnormal and clinically relevant changes in pulse rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Incidence of abnormal and clinically relevant changes in supine blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: improvement of home blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Prevention of uterine atony
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Drug levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PDE2A Brain Enzyme Occupancy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Anthropometric characteristics
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Level of Caregiver Distress
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Occurrence of hemi-diaphragmatic paresis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Morphological Complete Response Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complete Measurable Residual Disease (MRD) Response Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PrEP prescription filled
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Change in headache diary variables
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: humoral and cellular immune response
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: brain-specific progression free survival rate
Endpoint domain: Mortality/survival
Primary endpoint: Abscopal Response Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Residual platelet activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Requirement for allogeneic red cell transfusions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Oxygen levels in blood gas sample
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change in Exercise Time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Patients with Dose Limiting Toxicity (DLT)
Endpoint domain: Adverse events/effects
Primary endpoint: Safety of the malaria vaccine
Endpoint domain: Adverse events/effects
Primary endpoint: Change in 7-day Actigraph MVPA
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pink Esthetic Score (PES)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Papilla Index (PI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: The emergence of epileptic seizure
Endpoint domain: Adverse events/effects
Primary endpoint: Fraction of expired NO (FeNO)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Sedation-induced adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Sleep Efficiency-measured With PSQI
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Change in Conjugated/Direct Bilirubin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Frequency of Any Medically-attended Adverse Events (MAAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Any Serious Adverse Events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of red blood cell transfusions to the newborn
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Intraventricular Haemorrhage incidence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Maternal postpartum haemorrhage incidence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes