TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Swimming time for 400 m
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Lung cancer screening intention and uptake
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of participants with adverse event of special interests (AESIs)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of participants with AEs leading to study intervention discontinuation
Endpoint domain: Adverse events/effects
Primary endpoint: Disabilities of arm, shoulder and hand (Quick DASH) questionnaire
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: numerical pain rating scale (NRS) score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Isometric shoulder muscle strength for abduction and internal/external rotation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Incidence of Nausea and vomiting
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Skin Elasticity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Change in Skin Hydration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: eNutri dietary intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Adverse events at post-interventional 1 months
Endpoint domain: Adverse events/effects
Primary endpoint: Elevated hemoglobin value
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Health Related Quality of Life in PCOS
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Incidence of hospital admission
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 6 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Mean Change from Baseline in Interleukin (IL)-6 at 6 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Mean Change from Baseline in Fasting blood glucose at 6 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean change in cumulative past 24-week seizure frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Mean change from baseline to 24 weeks in Quality of Life (QOL)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Pain NRS scores at 24 h after craniotomy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reach (Aim 1)
Endpoint domain: Life impact
Endpoint subdomain: null
Primary endpoint: Fidelity (Aim 1)
Endpoint domain: Life impact
Endpoint subdomain: null
Primary endpoint: Cost (Aim 3)
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: diagnostic performances
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in International prostate symptom score (IPSS/QoL)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Proportion of patients achieving CCCA
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: 1-hour Pad test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage score on the Oxford Ankle and Foot Questionnaire for Children (OXAFQ-C)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Recurrence of ankle sprain
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of Adverse event (AE)
Endpoint domain: Adverse events/effects
Primary endpoint: Puncture /drainage-Free Survival (PuFS)
Endpoint domain: Mortality/survival
Primary endpoint: Change in eccentric hip adduction strength
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change in hip joint range of motion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Bispectral Index sedation Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Right ventricular volumes change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Combined AUC for Selected Symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AE occurrence
Endpoint domain: Adverse events/effects
Primary endpoint: ablated tissue assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Pain pressure Threshold
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pain Body Diagram
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of patients with HBV DNA <2000 IU/ml, normal ALT and no significant fibrosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Real-World Progression-Free Survival (rwPFS) as first line treatment
Endpoint domain: Mortality/survival
Primary endpoint: Real-World Progression-Free Survival (rwPFS) as second line treatment
Endpoint domain: Mortality/survival
Primary endpoint: Change of skeletal muscle strength
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change of physical performance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in COVID-19 Prevention Practices
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Nausea episodes
Endpoint domain: Adverse events/effects
Primary endpoint: Retching episodes
Endpoint domain: Adverse events/effects
Primary endpoint: Prospective memory reaction time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Executive controlling functioning
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Respiratory function test (Spirometry)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of hours patient adhered to PAP therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: MRI measures
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Alcohol Urge Questionnaire (AUQ)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Experience of self management
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Change in the Visual Analogue Scale for pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: complete clinical response (cCR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Detection of fetal chromosomal abnormalities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent of patients showing clinical improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: effectiveness of Legalon®
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Childbirth Self Efficacy
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Cumberland Ankle Instability Tool (CAIT)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Foot and Ankle Ability Measurement (FAAM)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Proportion of women with primary postpartum hemorrhage after vaginal delivery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of newborns with APGAR score <7 at 5 minutes' assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Skills score of maternal and newborn health service providers on Essential Care for Labor and Birth (ECLB), Bleeding after Birth (BAB), and Helping Babies Breathe (HBB) module
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Unified Parkinson's Disease Rating Scale (UPDRS-III)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Hoehn and Yahr Staging Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: ACE and ACE2 activities in monocytes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Pain and functionality
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of patients with acute pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Manchester-Oxford Foot and Ankle Questionnaire score
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Area Under the Concentration Versus Time Curve (AUC [0-∞]) of Simvastatin and simvastatin acid
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Concentration (Cmax) of Simvastatin and simvastatin acid
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Finger pulse oximetry
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Patient-Reported Pain Scores on the Visual Analog Scale (VAS)
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Occurrence of treatment emergent adverse events (TEAEs) overall
Endpoint domain: Adverse events/effects
Primary endpoint: Improvement of knee pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Severity of lung dysfunction based on nucleocapsid antigen serum levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Severity of lung dysfunction based on interleukin-6 serum levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of episodes of aspiration pneumonia
Endpoint domain: Adverse events/effects
Primary endpoint: Clinical improvement in pneumonia symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reactogenicity of SCB-1019 vaccine
Endpoint domain: Adverse events/effects
Primary endpoint: Unsolicited AEs of SCB-1019 vaccine
Endpoint domain: Adverse events/effects
Primary endpoint: SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019 vaccine
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants Who Achieved Low Disease Activity (LDA)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Bristol Stool Scale (BSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Romes-IV criteria
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Constipation Assessments Scale (CAS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: specialist referrals
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: diagnostic orders
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: 1 year Progression-free survival
Endpoint domain: Mortality/survival
Primary endpoint: e-cigarette use frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: e-cigarette use quantity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of patients who adequately read informed consent forms
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Accuracy of glucose readings
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Need for oxygen therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Ascension of sensory block level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in Oxygen Reserve Index (ORi)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Unassisted Maturation by 180 days
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Freedom from access-related adverse events through 30 days
Endpoint domain: Adverse events/effects
Primary endpoint: Minimally Conscious State Detection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Cognitive Function Assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Bioequivalence based on Composite of Pharmacokinetics
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Concentration (Cmax) of Imlunestrant
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Concentration Versus Time Curve (AUC) of Imlunestrant
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Glucometer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Perceived stress scale
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Brain activity during fMRI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Stomach activity during MRI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: brain injury
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Finger Tapping Test (FTT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Nine-Hole Peg Test (9HPT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in blood eosinophil count
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Geometric Mean Titers (GMT) of HPV neutralizing antibodies
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Mesiodistal Angulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Metabolites in stool, urine and blood
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Changes in clinic systolic blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Changes in clinic diastolic blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Diagnosis of preeclampsia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: P. vivax recurrence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Stance phase percentage
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pain - Visual Analogue Scale
Endpoint domain: Adverse events/effects
Primary endpoint: Criminal Recidivism based on self-report
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Criminal Recidivism based on official police records
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Criminal Recidivism based on official judiciary records
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Truancy based on self-report
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Immunogenicity measured by serotype-specific IgG
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Non-inferiority measured by serotype-specific IgG GMC
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Overall Response Rate (ORR) at 3 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Overall Response Rate (ORR) at 6 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Biopsy proven graft rejection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Area Under Curve from 0 to the last point (AUC0-last)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Morphine usage
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Episodes of nausea or vomiting requiring medication
Endpoint domain: Adverse events/effects
Primary endpoint: Percent of pain absence
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change in Time In Range (TIR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of daily insulin injections irregularities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: side-effects from treatment
Endpoint domain: Adverse events/effects
Primary endpoint: Change in 6-Minute Walk Test distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Depression in pregnant women
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Anxiety in pregnant women
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Asthma Symptoms Improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Concentration of protein-bound toxins
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in blood lipid
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Changes in glucose status
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Phobia symptom severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of first case of P. vivax malaria
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of tracheal intubation procedures performed in accordance with guidelines
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: DRFV scores
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Caregiver primary subjective stress
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: dd-cf DNA levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Immunological events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Longitudinal DSA monitoring
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Hypoglycemia aggregate outcome
Endpoint domain: Adverse events/effects
Primary endpoint: Differences in HMO from mothers' milk
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Experience of physical abuse at MRMC
Endpoint domain: Adverse events/effects
Primary endpoint: Chedoke Arm and Hand Activity Inventory -9 (CAHAI-9)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Box and Block Test
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: The Motor Activity Log
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: NASA-Task Load Index (NASA-TLX)
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: European Quality of Life Five Dimension Questionnaire (EQ-5D)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Exercise-Induced Bronchoconstriction (EIB) Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: 16-km Cycling Time-Trial Time to Completion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety as measured by DLTs and drug related SAE's
Endpoint domain: Adverse events/effects
Primary endpoint: Tolerability and Efficacy measured by progression of disease through an ordinal scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Efficacy measured by time to resolution of respiratory failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Percentage of patients reaching the compound endpoint
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Completion of intended ERCP procedure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Chlorpromazine equivalent dose values
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Local Regional Relapse-Free Survival (LRRFS)
Endpoint domain: Mortality/survival
Primary endpoint: Change in Healthy Relationship Knowledge
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in Volition
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Change in Self-efficacy to resist peer pressure
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in Communication, Decision Making and Problem-Solving scale (CDP-Child Version)
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Clinically Significant Change from Baseline in Vital Signs
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes