TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Triglycerides response
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the functional capacity
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Percentage of Participants With Early Clinical Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of patients receiving appropriate diagnosis and treatment
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Mitochondrial energy metabolism
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: brain centers activation related to food intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Rate of recruitment to the studies
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Number of Participants With Any Serious Adverse Events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Evaluate the Dose Limiting Toxicities (DLTs) of CPX-POM
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of participants adherent to treatment (self-report and pill count)
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Percentage of participants adherent to treatment (drug dosage in plasma)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of participants adherent to treatment (treatment failure)
Endpoint domain: Adverse events/effects
Primary endpoint: Distribution of smooth muscle in Dartos
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: clinical pain score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Motor effects
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hospital Discharge
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: All-cause day-28 mortality
Endpoint domain: Mortality/survival
Primary endpoint: Incidence of high altitude pulmonary edema
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Positive and negative symptoms scale (PANSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: The Clinical Global Impression scales (CGI)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Blood lipids and blood glucose
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Clinically important perioperative atrial fibrillation/atrial flutter
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Myocardial injury after noncardiac surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Pediatric Asthma Quality of Life
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Daily seizure frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: CTCAE grade 4 of the blood marrow
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Sensitivity of the imaging modalities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of High Risk Patients Who Develop Steroid Refractory GVHD
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Effective doses of inhaled nitric oxide
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of patients deriving clinical benefit
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: repigmentation of vitiligous lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Sensitivity of models for diagnosis of memory disorders
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Specificity of models for diagnosis of memory disorders
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Accuracy of models for diagnosis of memory disorders
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Local oxygen saturation in the brain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in baseline visual acuity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in baseline intraocular pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: percent change of apoB/A1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of acneiform lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Incidence of early onset neonatal sepsis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Immunogenicity measured by haemagglutination inhibition (HI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Mean pct950
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from PRE in workload at 6 weeks (POST)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from PRE in absolute oxygen uptake at 6 weeks (POST)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from PRE in heart rate at 6 weeks (POST)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Difference in systolic and diastolic BP
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Conners
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Intraclass coefficient of correlation of the ultrasound volume measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Chronic lung disease or death
Endpoint domain: Mortality/survival
Primary endpoint: Change in estimated Blood Alcohol Content (eBAC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in number of alcoholic drinks consumed
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Insomnia Severity Scale (ISI) score
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Seroconversion by PRNT50
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Kendall's manual muscle testing
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Serum creatine kinase (CK) levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Childhood myositis assessment scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: expression of the marker CD10
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Need for surgical completion for incomplete abortions or ongoing viable pregnancies
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Safety of HUMENZA and PANENZA vaccines
Endpoint domain: Adverse events/effects
Primary endpoint: Changes of bone remodelation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: sleep assessed by EEG power
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Total Dose of Opioids Received
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: OMERACT RAMRIS Synovitis Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Total alcohol abstinence
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Cumulative abstinence duration
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of Participants who Experience at Least 1 Treatment Emergent Adverse Event (TEAE) During the Study
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants who Meet the Markedly Abnormal Value for Safety Laboratory Tests at Least Once Postdose During the Study
Endpoint domain: Adverse events/effects
Primary endpoint: Mean Sleep Latency Over Four Maintenance of Wakefulness Test (MWT) Sessions After Initial Dosing
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Standard laboratory tests
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of lymphocyte TCD4 Th17 in colon sample
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Variation in lymphocyte subpopulations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Total pain rated on numeric rating scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline urine inflammatory profile
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Myofibrillar protein synthesis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of Participants With Verified Smoking Cessation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Patient Health Questionnaire (PHQ-9) score from baseline
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in Beck Depression Inventory (BDI) score from baseline
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Reperfusion Rates
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Immediate post-procedural success
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Biovolume of Pseudomonas Aeruginosa biofilms in sputum
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Percentage of seroconversion to poliovirus type 1 and type 3
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Ease of use and Comfort scale
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Area Under the Curve of BI 1026706 (AUC0-tz)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Concentration of BI 1026706 (Cmax)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in cholesterol metabolism
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Rate of incorrectly placed caudal blocks
Endpoint domain: Adverse events/effects
Primary endpoint: Postpandrial glucose levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Total insulin secretion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: First phase of insulin secretion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Recommended Phase II Dose (RP2D) of CD33-CAR-T Cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
Endpoint domain: Adverse events/effects
Primary endpoint: Change of Muscle mass of the quadriceps
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change of Muscle quality of the quadriceps
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Alcohol problems
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Time to complete recovery of muscular lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Incidence of Complete Resection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Serum Vitamin D level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Function of the region covered by human acellular dermal matrix allograft
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Social Phobia Scale Score
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Number of migraine headache days
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: arginine stimulated C peptide
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: fasting C peptide
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: glycosylated hemoglobin (Hb A1c)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Incidence of Dose Limiting Toxicites (DLTs)
Endpoint domain: Adverse events/effects
Primary endpoint: Feasibility (Rate of Successful Completion)
Endpoint domain: Resource use
Primary endpoint: MEP0/MEP10 and MEP0/MEP30 values
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Endurance test execution time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cough-related Quality of Life (QoL)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Closure of recurrent macular hole
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Concentration of thrombin anti-thrombin complex (TAT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Changes in blood transfusion requirement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Generation of anti-idiotypic and anti-tumor immunologic responses
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Perception of catheterization
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in the rate of FEV1 decline
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Cumulative All-cause mortality
Endpoint domain: Mortality/survival
Primary endpoint: All cause and CLAD related mortality
Endpoint domain: Mortality/survival
Primary endpoint: Change From Baseline in Visual Acuity (VA)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: time of catheterization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Adherence to smartphone mobile health app
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Composite Measure of Glycemic Control - Complete Remission
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Composite Measure of Glycemic Control - Partial remission
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Composite Measure of Glycemic Control - Improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Body Awareness Questionnaire (BAQ)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Body Perception Scale (BPS)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Prevalence of the KRAS-variant
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Stringent complete response rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Long-term outcome after hip arthroplasty
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Absence of graft rejection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Geometric Mean Titers (GMTs) at Day 29
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Percentage of subjects with seroresponse 28 days after vaccination
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Spontaneous walking speed of 10 meters
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: QST parameters
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Quality of Recovery
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Diagnostic Quality of Images
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Acute change in Net whole body protein synthesis rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Complications related to EBUS-TBNA
Endpoint domain: Adverse events/effects
Primary endpoint: Return of Oxygen Saturation to Baseline (Sea Level) Values
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: middle-ear pressures
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Negative breath-hydrogen test
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: thigh cellulite appearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: psychosomatic distress
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Health related self-efficacy
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Bone quality (trabecular bone score)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Reproducibility of MRI techniques in measuring knee cartilage
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Comparison of EtCO2 and PaCO2 levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: PaCO2 variation under NIV
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: frequency of rising procalcitonin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Judgement of learning using a 5 point scale
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Skin irritation severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Contraceptive prevalence rate
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Diagnostic Interpretability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Composite performance score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in anhedonia
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in social development
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Change in emotional development
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Reduction in estimated glomerular filtration rate (eGFR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Sexual/Reproductive Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Inhibition of uric acid crystallization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in ptosis on myasthenia gravis composite scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in ptosis index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in lip length index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in lip purse index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of vaginal delivery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Incidence of urgent cesarean section
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Visual Analogue Scale (VAS) for itching
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pruritus Ani Severity Index score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of participants with dose limiting toxicities
Endpoint domain: Adverse events/effects
Primary endpoint: Changes in mean NEI-VFQ-25 overall scores
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Conner's Parent Rating Scales-Revised (CRS-R)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing