TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Pain free surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Intraluminal Bubbles Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 24 hour dietary intake from CIR-24
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Urine concentrations of caffeine and 8 additional metabolites
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Maximum Tolerated Dose (MTD) of Afatinib
Endpoint domain: Adverse events/effects
Primary endpoint: Pharmacokinetics of atazanavir/ritonavir and tenofovir
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: RF time to successful ablation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Cough Reflex Sensitivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Non-motor symptom progression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Topotecan
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of VX-970 (M6620)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Objective Response Rate (Partial Response + Complete Response)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Area under the plasma concentration-time curve (AUC) of Andrographis paniculata
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cmax of Andrographis paniculata
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tmax of Andrographis paniculata
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cmax of Metformin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tmax of Metformin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of AEs Per Severity (All Courses)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of HDMTX Related AEs Per Severity (All Courses)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Ongoing AEs Per HDMTX Course
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Ongoing HDMTX Related AEs Per HDMTX Course
Endpoint domain: Adverse events/effects
Primary endpoint: Number of VT/VF episodes after randomization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Duration of VT/VF episodes after randomization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: 24hr energy expenditure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: sleeping energy expenditure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Baseline presentation of patients with JCV infection and/or PML
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: increase in the abdominal circumference
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Food Literacy
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: number of patients
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Optimality of care
Endpoint domain: Life impact
Endpoint subdomain: Delivery of care
Primary endpoint: Respiratory Adverse Events Per Subject
Endpoint domain: Adverse events/effects
Primary endpoint: Oral Cancer Death Rate
Endpoint domain: Mortality/survival
Primary endpoint: Limb length discrepancy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Limb Angular alignment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of CPERT
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency & Severity of Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Normal live-born delivery
Endpoint domain: Mortality/survival
Primary endpoint: Pre-term birth (prematurity)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Cmax (maximum observed concentration of drug substance in plasma)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC0-inf (area under the concentration-time curve from time zero to infinity)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improvement of physical activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Participants Depressive Symptoms
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Time to Loss of Asthma Control (LOAC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Bone Density of the hip
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: number of participants with malignant biopsy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Overall Rate of Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical Response at 30-day Completion of Fidaxomicin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in scoliosis severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Total volume of fluid infused intraoperatively
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: fMRI measurement (activation and functional connectivity)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Participant retention 6 months postpartum
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Participant retention 12 months postpartum
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Gut function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Peak calcium responses to bradykinin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Feasibility of HeartMapp+CT app usage
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Smoking Lapse
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Adverse events assessed according to NCI-CTCAE V5.0
Endpoint domain: Adverse events/effects
Primary endpoint: iAUC of blood glucose
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change from Baseline in health-related quality of life
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Rate of progression from moderate to minimal assist
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in NIR
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in CR
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: MMP Activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in exercise duration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of patients achieving 50% pain reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean difference in plasma concentration for two drugs
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Response Conversion Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Absolute bioavailability (F) of Acalabrutinib for Cohort 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib and [14C]ACP-196 for Cohort 1 and Cohort 2
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Concentration (Cmax) of Acalabrutinib and [14C]ACP-196 for Cohort 1 and Cohort 2
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Maximum tolerated dose of dovitinib lactate
Endpoint domain: Adverse events/effects
Primary endpoint: Event free survival (Cohort A: Arm A compared to Arm C)
Endpoint domain: Mortality/survival
Primary endpoint: Complete response rate (Cohort B1)
Endpoint domain: Mortality/survival
Primary endpoint: Event free survival (Cohort B2)
Endpoint domain: Mortality/survival
Primary endpoint: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change From Baseline in Overall Knee Injury and Osteoarthritis Outcome Score (KOOS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Emotion-regulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: HbA1c change over time
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change of hydrogen levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Change in muscle volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Molecular characterization
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in length
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Amount of opiate used
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Maximum tolerated dose of temozolomide
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: T-cell receptor profile changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in scooter skills capacity
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: number of patients with cardiac complications
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Cue-induced craving
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Perceived usefulness scores
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Seizure induction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Quality scores difference
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: HR variability
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Electroneuromyography results
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Physical Examination findings
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: overall cumulative Lynch syndrome cancer
Endpoint domain: Mortality/survival
Primary endpoint: Serum LPS rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Successful operation of IMMAGES system
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Serum and/or follicular minimum level of G-CSF
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of patients evaluated within SETS objectives
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Normalization of brainwaves
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Presence of urinary retention
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change in Sleep Onset Latency (SOL)
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: bleeding profile
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: endocan levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: copeptin levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Increase in Breast Milk Production
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of words named in a category
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Screening Rates
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Medication Discontinuation
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Occurrence of Neutropenia ≥ Grade 3
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Occurrence of Thrombocytopenia ≥ Grade 3
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Occurrence of Anemia ≥ Grade 3
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Occurrence of Lymphopenia ≥ Grade 3
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Occurrence of CPK Increase ≥ Grade 3
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency of Occurrence of Increase ALT and / or AST ≥ Grade 3
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence Rate of Composite Efficacy Failure (tBPAR, Graft Loss or Death)
Endpoint domain: Mortality/survival
Primary endpoint: Change in serum High Density Lipoprotein (HDL)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Viral eradication time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sensitivity of MRI to detect lung changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Radiographic imaging
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Blood levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Volumetric bone regeneration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Linear bone regeneration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Resolution of shock state
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduced Glutathione (GSH) Concentrations in Red Blood Cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Superoxide Dismutase (SOD) Activity in Red Blood Cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: C-Reactive Protein (CRP) Concentrations in Plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Bone marrow undetectable-minimal residual disease (MRD4)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: 6-month hospital discharge
Endpoint domain: Mortality/survival
Primary endpoint: Decrease in saturated fat intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Decrease in total sugar intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Decrease in total sodium intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: gynecological cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: serious cardiovascular diseases
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Blocking of S1 and S2 dermatomes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Use of LACM and permanent contraception methods
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: 30 Second Chair stand test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Arm Curl Bicep Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 6 minute walk Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinically cleared actinic keratosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Histological evaluation for relapse
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Presence of viable tissue at CLM
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Volume of blood in the capillary tube
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: rate of implementation of recommendations concerning mobility
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Occurrence of vaso-occlusive complications
Endpoint domain: Adverse events/effects
Primary endpoint: PedsQL Gastro
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Changes in dentoskeletal cephalometric measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Periodontal status
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Motor Performance of Unified Parkinson's Disease Rating Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of voluntary blood donors
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Power-mobility Indoor Driving Assessment (PIDA)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Overall radiological response rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: distribution of pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hyperglycemic potential
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Accommodation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Capacity of tolerating a nutrient drink
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Recurrence of the original cancer
Endpoint domain: Mortality/survival
Primary endpoint: Development of a new gastric cancer
Endpoint domain: Mortality/survival
Primary endpoint: Change in early morning COPD symptom severity score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in night time COPD symptom severity score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: any-grade incidence of side-effects at the extremities
Endpoint domain: Adverse events/effects
Primary endpoint: Severity of emergence delirium
Endpoint domain: Adverse events/effects
Primary endpoint: Unawareness of Mental Disorder
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Levels of High Density Lipoprotein C (HDL-C)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Levels of White Blood Cells (WBC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: recurrence of silent stroke
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: recurrence of AF after rhythm control
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Revised ALS Functional Rating Scale (ALSFRS-R)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes of cardiac output
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Function as demonstrated by Quick score
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Recurrence of varicose vein
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Mean base excess during hospital stay
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prevalence of COVID-19 infection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: In-lesion Restenosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Improvement in Ocular Surface Disease Index (OSDI) scores
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Cumulative 112-day Exit Rate
Endpoint domain: Mortality/survival
Primary endpoint: Percentage of compliance
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Solicited injection site and systemic reactogenicity
Endpoint domain: Adverse events/effects
Primary endpoint: Unsolicited adverse events (AE), medically-attended adverse events (MAEs), and serious adverse events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Counts and percentage of term healthy infants appropriate for gestational age
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in the Iowa Gambling Task net score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes