TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Change in Working Memory Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in Neurophysiologic Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in Level of Everyday Functioning
Endpoint domain: Life impact
Endpoint subdomain: Functional outcomes
Primary endpoint: Change in General Cognitive Ability
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Area under the curve (severe)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Average daily pain intensity
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: ctDNA content
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Endoxifen blood concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Assessment of the redness of the eye
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Degree of irritation of the tested eye
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Adverse reactions and adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Neuropsychological tests
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Total and Regional Brain Compartmental Kinetics for Volume of Distribution (V[t])
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percentage of Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA gamma 8) Receptor Occupancy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percentage of Participants Achieving A Clinical Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Overall survival from initiation of first systemic anticancer therapy
Endpoint domain: Mortality/survival
Primary endpoint: Progression free survival from initiation of each systemic anticancer therapy separately
Endpoint domain: Mortality/survival
Primary endpoint: Time to treatment failure from initiation of each systemic anticancer therapy separately
Endpoint domain: Mortality/survival
Primary endpoint: Change from baseline in Pain Scores on the Visual Analog Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Range of Motion of cervical spine
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change in symptoms of nerve root compression
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Diagnosis of Coronary Heart Disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Melbourne Assessment of Unilateral Upper Limb Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hand Path Ratio (HPR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Device Tidal Volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Rib Fracture Subjective Self-Reported Pain (Inpatient)
Endpoint domain: Life impact
Endpoint subdomain: Pain
Primary endpoint: Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Inpatient)
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Home)
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Functional long-term properties clinical performance of restorations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Esthetic properties of restorations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Biologic properties of restorations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Progression of cognitive deficits
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Plasma Glucose Concentrations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Insulin Concentrations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Clinical relevant fat necrosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: dentinal tubule penetration of sealer
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: interaction of extract of sapindus mukorossi with hypochlorite
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
Endpoint domain: Adverse events/effects
Primary endpoint: composite incidence of cardiovascular and/or neurological complications including vascular death
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: composite incidence of cardiovascular and/or neurological complications including vascular death
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: composite incidence of cardiovascular and/or neurological complications including vascular death
Endpoint domain: Mortality/survival
Primary endpoint: Blood samples obtained
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Key ECG findings
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Incidence rates of standard infusion reaction (SIR)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of grade 3-5 Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Change in the proportion of patients with moderate and severe erectile dysfunction
Endpoint domain: Life impact
Endpoint subdomain: Sexual functioning
Primary endpoint: Number of women undelivered 48 hrs and seven days of initiation of therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Babies with Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Vineland Adaptive Behavior Scales II
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: 24-hour urinary sodium
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Biomarkers to treatment response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Kinetic interaction evaluation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change From Baseline in FEV1 AUC0-4
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: pH of saliva
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of tissue engineered laryngotracheal replacement
Endpoint domain: Adverse events/effects
Primary endpoint: Flow mediated dilation (FMD) for endothelial function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: current pain level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the levels of pain perception
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in the levels of discomfort perception
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Incidence, severity and dose-relationship of adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: MEG Contrasts of parameter estimates
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: aneurysm exclusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Detection of TRPV1 gene polymorphisms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Detection of KCC2 gene polymorphisms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Plasma concentrations of sofosbuvir
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Milk concentrations of sofosbuvir
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Plasma concentrations of daclatasvir
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Milk concentrations of daclatasvir
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Child's Anxiety
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28
Endpoint domain: Mortality/survival
Primary endpoint: Reduction in Oswestry Disability Index (ODI)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: CD4 number
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: VIH level in platelet
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Percentage of Participants Who Achieved 2 Grade IGA Reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Changes in pain inhibition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in psychomotor vigilance and alertness
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Changes in selective attention and executive function
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Temperature of the ipsilateral palm of the hand
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of successful manufacture of CD22 CAR T cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safe dose of CD22-CAR T cells in subjects with R/R B-cell malignancies
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Major Bleeding Events (MBE)
Endpoint domain: Adverse events/effects
Primary endpoint: Symptomatic Venous Thromboembolic Events (sVTE)
Endpoint domain: Adverse events/effects
Primary endpoint: All-cause Mortality Events
Endpoint domain: Mortality/survival
Primary endpoint: Mean Bone Mineral Density Changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Limbs Fat Changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Delivery of standard clinical care
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: renal graft function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Types and frequencies of adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Types and frequencies of serious adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Stress urinary continence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Normoprolactinemia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Fractional Iron Absorption
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Necessity of routine neck node dissection
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Concentration of HbA1c
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Percentage of Participants With Inpatient Psychiatric Hospitalization
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Changes in Burkholderia spp. density
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants Who Experienced a Treatment-emergent AE (TEAE)
Endpoint domain: Adverse events/effects
Primary endpoint: Liver triglyceride content
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Decision Quality
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: gastrointestinal change score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: mean Flushing Severity Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: maximum Flushing Severity Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Difference in time-matched glucose levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Difference in body-fat percentage
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: LENA Adult Word Count Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Absolute Bioavailability of CAT-354
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peel force
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Plasma Concentration of TA-7284
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Urinary Glucose Excretion of TA-7284
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Craving score change
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Right Ventricle/Left Ventricle (RV:LV) Ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Major Adverse Event Rate
Endpoint domain: Adverse events/effects
Primary endpoint: tendon bone healing
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: ligament maturing
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Number of Impedance Episodes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Inflammatory Markers
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Physical exams
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Endoscopic Score - Cryer Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Endoscopic Score - Modified Lanza Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Histopathological Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Lumen Loss
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Re-intervention rate
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Quality of spontaneous movements of the infants
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: On-going gestation (beyond 8 wks)
Endpoint domain: Mortality/survival
Primary endpoint: Changes in short-chain fatty acid production by gut microbiota
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Time in Target Range
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction in the loss of autonomy
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Reduction of prostatic calculated volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical response as per partial Mayo score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of urge urinary incontinence episodes per 24 hours
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: AUC0-t,ss of Empagliflozin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Cmax,ss of Empagliflozin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: AUC0-t,ss of Lobeglitazone
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Cmax,ss of Lobeglitazone
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Incidence of infusion-associated reactions
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of anti-drug antibodies (ADA)
Endpoint domain: Adverse events/effects
Primary endpoint: Change in rate of dysphagia symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Muscle volumes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Progression of cirrhosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Liver outcomes
Primary endpoint: Severity of morbidity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Severity of mortality
Endpoint domain: Mortality/survival
Primary endpoint: Drug Liking
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Mini-Mental State Examination Change From Baseline
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Facial wrinkles severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Global aesthetic improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Skin pigmentation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Histopathology improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants With Infusion-site Thrombophlebitis
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With Severe Infusion-site Reactions
Endpoint domain: Adverse events/effects
Primary endpoint: Change in degree of mucositis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in mucositis symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Stricture Resolution
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Any toxic effect reported during MSCs infusion or in the subsequent 10 days
Endpoint domain: Adverse events/effects
Primary endpoint: Change of the systolic blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change of the diastolic blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change of the mean blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change of the heart rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: overall joint stability
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Composite Complete Remission (CRc) Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maternal anti-EV71 levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Consistency rate of drug sensitivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Freedom From Aortic Insufficiency More Than 2+
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: non-invasive fat reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: circumference reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to Wound Healing
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: postprandial insulin sensitivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: forearm muscle fatty acid handling
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Decreased Wound Size
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Maximum tolerated dose (MTD)/maximum feasible dose (MFD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Change in scores on Beck Scale for Suicidal Ideation
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of Participants With Protocol Specified Dose-limiting Toxicities
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With AEs and Clinical Laboratory Abnormalities
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of infants achieving target trough vancomycin concentrations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Persistence of high blood pressure (hypertension)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes