TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Adequate placement of the central venous catheter
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change of the Korean-Montreal cognitive assessment (MoCA) score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Density of Hemoglobin SC Red Cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Safety of the personalized polyepitope DNA vaccine
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Maximum Amplitude at 1-hour Post-transfusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Patient Discomfort
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Percentage of patients taking 6 or more tablets on-demand per week
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ADP induced platelet aggregation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Prevalence rate of stroke
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Prevalence rate of hypertension
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Prevalence rate of diabetes mellitus
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Prevalence rate of dyslipidemia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in disease-related quality of life
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Percentage rate of responders
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Changes in the secretion pattern of incretins, insulin and glucagon
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Correct localization of the ictal onset zone
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Number of polypectomies for competency
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Feasibility of implementing pharmacogenetics to guide antiplatelet therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Feasibility of implementing platelet reactivity testing to guide de-escalation of antiplatelet therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Root Coverage Esthetic Score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Percentage of participants with a 50% decrease in Total neuropathy score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Volume of Distribution (L/Kg) of Amikacin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clearance (L/h) of Amikacin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PK/PD targets of amikacin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent change in calculated LDL-C
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Presence of Pseudomonas aeruginosa in chronic wounds
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Occurrence of treatment-related adverse events (AEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Improvement in hematopoiesis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Time to fulfilling discharge criteria
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum plasma Concentration (Cmax)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in HRS-D17
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Genetic polymorphism changes in knee muscles
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Number of Days With Any Individual Gastrointestinal Symptom
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Seroprotection for Measles Virus Serum Neutralization Antibodies
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Bacterial Counts
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Gene Expression Analysis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mortality - Cause
Endpoint domain: Mortality/survival
Primary endpoint: Mortality - Date
Endpoint domain: Mortality/survival
Primary endpoint: Change from baseline in perfusion brain SPECT
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change from baseline in neuropsychological assessment scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Endometrial distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: test accuracy of water-soluble contrast enema for detection of colorectal anastomotic leaks
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: test accuracy of MRI-Enema for detection of colorectal anastomotic leaks
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Level of completion of all items in the video call-completed ADRe Profile
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical impact on service users, including new problems identified and problems addressed
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Description of stakeholder views on ADRe Profile implementation effectiveness
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: functional MRI (fMRI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Shrinkage of mesh surface after implantation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: MATRICS Cognitive Battery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Morphine Requirement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: DFN-15 maximum plasma concentration (Cmax)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: DFN-15 area under the curve (AUC) 0-t
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: DFN-15 area under the curve (AUC) 0-inf
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximal oxygen-flux
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Covid (Coronavirus Disease-19) Ordinal Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in 24-hour Mean Ambulatory SBP
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Fasted serum glucose
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Infant mental development
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of Retention in Treatment
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Rate of patients with at least one sustained VTA
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Lip to carina length
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Management of aortic and retroperitoneal fibrosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: TAT complex generation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Adherence to weekly BP recording at 3 months
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Adherence to weekly HR recording at 3 months
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Cumulative Abstinence Duration
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Pathologic enhancement of the facial nerve
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percentage of complete wound closure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Total apoC-III
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Arterial revascularizations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Rotational stability of the investigated toric lens
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Elimination of symptoms associated with immature swallowing
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Structure preservation rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: proportion of patients with IGA score of 0 or 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fatigability from WAIS-III - Coding
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Fatigability on e-prime vigilance (reaction time) task in the fMRI scanner
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Medication Persistence
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in rotational stability of the toric intraocular lens (T-IOL)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Self-Reported Craving Level
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: 10 Meter Walking Speed
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: severity and type of CDI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: serious adverse reactions
Endpoint domain: Adverse events/effects
Primary endpoint: Microvascular myocardial perfusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Anti-HBs Titres (IU/L)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Assessment of Memory T Cells and HBsAg-specific-proliferation of CD3 + CD4+ TH Cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: duration of vasoplegia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Proportion of biopsy cores positive for clinically significant cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Eradication of LGD and HGD within BE
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Galectin-3 measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Quantity of adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Quantity of serious adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Pain Control Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Musculoskeletal Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change From Baseline In ALSFRS-R Total Score
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Mean change in Hamilton Depression Rating Scale 17 (HDRS-17) score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Inhibition of midazolam clearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Cognitive Function Score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations Above the Cut-offs
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Successful intravenous catheterization on the first attempt
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Growth velocity (weight gain in g/day)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Detection of FGF-1 mRNA
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Nasal symptoms score (TSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to complete fragmentation of renal calculi
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Number of Participants With Clinical Safety Laboratory Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants Reporting Vaccine-related Medically Attended Adverse Events (MAAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: fatigue change
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: quality of life change
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: AUCINS.0-4h
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: AUCGIR.0-4h
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: liver fat change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change from baseline in proteinuria
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Incidence of Chronic Post-thoracotomy Pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximal storage time with acceptable recovery and survival
Endpoint domain: Mortality/survival
Primary endpoint: Adverse events as assessed by CTCAE version 4.0
Endpoint domain: Adverse events/effects
Primary endpoint: MTD of axitinib based on dose-limiting toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: serum protein profile predicting sensitivity or resistance to gemcitabine/carboplatin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Cumulative adverse event (AE) rate (moderate or severe)
Endpoint domain: Adverse events/effects
Primary endpoint: Adverse Events Leading to Permanent Discontinuation of Study Drug
Endpoint domain: Adverse events/effects
Primary endpoint: Brain swelling
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Post operative liver injury
Endpoint domain: Physiological/clinical
Endpoint subdomain: Liver outcomes
Primary endpoint: Total Opioid Intake in Morphine Milligram Equivalents
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: FVIII half-life
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Volume in steady state
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Readiness of parents
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Serum HDL (high-density lipoprotein)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Good oral hygiene measured by plaque index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: [18F]NAV4694 PET visual assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Dose of fentanyl
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PFR-MCA hydrolysis by circulating IgG
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Functionality with patient specific function scale
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Disabilities with Oswestry disability index(scale)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Frequency and intensity of individual episodes of PONV
Endpoint domain: Adverse events/effects
Primary endpoint: ACR20 Responder Index Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Reduction of apnea/hypopnea index
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Reliability Ratings
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of complete wound closure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Time-to-onset of Heartburn Relief
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Score of episodic memory
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Score of executive psychometric tests
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Total plasma clearance of drug after IV administration (CL/F)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Change in Meibomian Gland Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Diurnal changes of the corneal radii
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Orientation of the steep meridian
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pertussis antibody titre
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Flu geometric mean of titres ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Therapy Failure
Endpoint domain: Adverse events/effects
Primary endpoint: Guideline adherence indicator
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Pre-dose Percent Predicted Forced Expiratory Volume in One Second (FEV1) to Week 24
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Severity of depressive symptomatology
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Maximum tolerated dose (MTD) of GTI-2040 and gemcitabine hydrochloride
Endpoint domain: Adverse events/effects
Primary endpoint: Adverse events graded according to the NCI CTC v3.0
Endpoint domain: Adverse events/effects
Primary endpoint: Changes in gene expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Total duration of self-catheterization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Intraventricular Hemorrhage number and severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Immunogenicity with respect to components of the investigational vaccine Day 0
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Immunogenicity with respect to components of the investigational vaccine Day 42
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Occurrence of Grade 3 injection site pain
Endpoint domain: Adverse events/effects
Primary endpoint: Clinical Global Impression (CGI) Severity Scores
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in Affective Reactivity Index - Youth (ARI-Y)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Clinical Global Impression: Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes