TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Change in Fugl-Meyer Assessment Score for Upper Extremity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Individuation Index
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Percentage of participants with no residual surviving tumor cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Percentage of participants with ≤10% tumor cell survival
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Change in Apathy
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Success rate of atrial septal puncture
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: X-Ray exposure time
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Presence of semen in the cap
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction of Back Pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Ascites objective response rate (ORR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: SCD variability between study and control group
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: MT-ATP6 gene variability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Numbers of TOFI and FOTI phenotypes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: hematoma expansion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Recurrence of intracerebral hemorrhage
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Cerebrovascular death
Endpoint domain: Mortality/survival
Primary endpoint: Changes in Bruxism Symptoms (The Fonseca Anamnestic Index)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in Bruxism Symptoms (Subject Global Aesthetic Improvement Scale)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Changes in Bruxism Symptoms (Basic Scale on Insomnia Complaint and Quality of Sleep)
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Absolute difference in PEEP recommendations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of subjects with thoracic aorta dilatation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Safety of AZD5156
Endpoint domain: Adverse events/effects
Primary endpoint: Safety of AZD3152 and EVUSHELD
Endpoint domain: Adverse events/effects
Primary endpoint: Prevention of symptomatic COVID-19
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Subacromial space measurement by Ultrasonography
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: The Disabilities of Arm, Shoulder and Hand Questionnaire
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: The Western Ontario Rotator Cuff Index
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Bone Height Changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Leisure-Time Physical Activity (LTPA)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Occupational Physical Activity (OPA)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Work Ability
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Gleason grade progression
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Discontinuation of active surveillance
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: International Prostate Symptom Score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Sexual Health Inventory for Men score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: percentage of AI-generated content
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Structure & Organization
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate Writing Clarity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of Knowledge
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time-to-reach Employment
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Fit-for-discharge time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Depression Changes
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of women with amenorrhea
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: 4 Meter Gait Speed Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of PPAP (Postpancreatectomy Acute Pancreatitis)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Significance of biochemical changes (postoperative hyperamylasemia and hyperlipasemia)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of Use of ITC
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Rate of Use Health applications
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Progression of glomerular diseases
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC[0-∞] of Warfarin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mortality rate at Day 90
Endpoint domain: Mortality/survival
Primary endpoint: Transfer to a higher level of care
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: 28-day ventilator-free days
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Challenging Behavior
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in sputum bacterial load
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Proportion with bacterial load >=10(6) colony forming units/ml
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: telomere length of cumulus cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tolerability of inhibition as measured by incidence of dose limiting toxicities (DLTs)
Endpoint domain: Adverse events/effects
Primary endpoint: Change in postpartum anxiety
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in postpartum family planning
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Tolerability of nature-based virtual reality
Endpoint domain: Adverse events/effects
Primary endpoint: Feasibility of nature-based virtual reality
Endpoint domain: Resource use
Primary endpoint: Acceptability of nature-based virtual reality
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Safety and tolerability of TH104
Endpoint domain: Adverse events/effects
Primary endpoint: Surface Luster (success rate)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety and tolerability of 225Ac-DOTATATE
Endpoint domain: Adverse events/effects
Primary endpoint: Recommended phase II dose of 225Ac-DOTATATE
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sensitivity for colorectal cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Specificity for colorectal cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Patient Enrollment Rate
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Patient Completion Rate
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Side Effects Profile
Endpoint domain: Adverse events/effects
Primary endpoint: Impact of Dysmenorrhea on Daily Life
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Prevalence of CKD-aP
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Number of participants recording data
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Surgeons experience
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Short Form-36 (SF-36) scores
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Endometrium volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Spillage Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prolonged Grief Scale-12
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Overall provider adoption of evidence based practices
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: TCM body constitution
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: TCM pattern types
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Drop in Apnea Hypopnea Index
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Global cure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: masticatory muscle activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: masticatory muscle balance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Acceptability and satisfaction
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Feasibility assessment
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Repeatability of IOP measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of prescription of oral LDL-C-lowering therapy
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Number of patients infused with planned target dose
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Number of patients with SpO2 below 93%
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Accuracy to detect positive invasive margins
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Diagnostic accuracy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Cranio-vertebral Angle
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Depression / Anxiety
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Sentinel lymph node technique accuracy in ovarian cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PPV and NPV of sentinel lymph node procedure in ovarian cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of participants reporting any grade 3 adverse event (AE)
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of participants reporting any serious adverse event (SAE)
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of participants reporting any adverse events of special interest (AESIs) grade 3 or higher
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of participants who achieve sustained virologic response (SVR) for 24 weeks
Endpoint domain: Physiological/clinical
Primary endpoint: Recurrent rate of IgG4-RD
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Feasibility questionnaire, overall study success
Endpoint domain: Resource use
Primary endpoint: Proportion of patients with acetabular erosion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Cannabis reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Recovery time after dialysis session
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: temperature change (flow)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Postoperative innate immune function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Pregnancy outcomes in women with COVID-19
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Change from baseline in cognition and neuropsychiatric status as assessed by Montreal Cognitive Assessment (MoCA)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Observed values and change from baseline in Systolic Blood Pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Absolute bioavailability of Ceralasertib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pharmacokinetics (PK) of Ceralasertib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Excretory routes of Ceralasertib and its metabolites
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants completing follow-up assessment
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Diagnostic performance for chronic heart failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Consensus of US images with ATFL injury classification
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the Social Adjustment Scale-Self Report
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Change in the MOS Social Support Survey
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Participant-reported flares of low back pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Tolerability Score
Endpoint domain: Adverse events/effects
Primary endpoint: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Concentration (Cmax) of Repaglinide
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peak change in plasma potassium levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Plasma potassium area under the curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Keratinized mucosa width
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in white adipose tissue dietary fatty acid (DFA) trapping and partitioning
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in lean organ (liver, heart and muscle) DFA uptake and partitioning
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in liver non-esterified fatty acid (NEFA) uptake, oxidation, esterification and secretion into very low-density lipoprotein (VLDL)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in Endogenous Glucose production and meal glucose systemic flux
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Improvement in wheezing score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: marginal bone changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Mean Acceptability of Intervention Measure (AIM)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Mean Feasibility of Intervention Measure (FIM)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of EIS Participants in Attendance
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Prevalence of Pulmonary Fibrosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Differences in circRNA microarrays before and after surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean difference in aortic pulse wave velocity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Mean difference in aortic augmentation index
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: pulmonary capillary wedge pressure (PCWP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number and proportion of newly diagnosed COPD
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Pain subscale of the SF-36 questionnaire
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change in Carotid Intima-Media Thickness (cIMT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Participants achieving glycated haemoglobin (HbA1c) less than 7%
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Participants achieving body weight reduction greater than or equal to 5%
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Seroconversion rate of the neutralizing antibody to SARS-CoV-2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Changes in clot microstructure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Changes in platelet reactivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Plasma concentration of coagulation factors
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Changes in capillary density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Changes in proliferative capacity of endothelial cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Percentage of Creatinine rise
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change from baseline sugar-sweetened beverage consumption
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Post-vaccination serological response rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Rate of abnormal histopathologic findings
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the complete remission rate
Endpoint domain: Mortality/survival
Primary endpoint: Change in Progression Free Survival (PFS)
Endpoint domain: Mortality/survival
Primary endpoint: Change in Overall Survival (OS)
Endpoint domain: Mortality/survival
Primary endpoint: Skin samples
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Verbal Fluency - Phonemic Fluency
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Verbal Fluency - Semantic Fluency - Episodic category
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Motor symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in the intensity of post-endodontic pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with insulin resistance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Diagnosis of OSAS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participant behavioural change choices on the Small Steps website
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: reduction of chronic pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of drug related AEs and SAEs
Endpoint domain: Adverse events/effects
Primary endpoint: Newborn Length for age z-score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from Baseline to Week 12 in Social Responsiveness Scale (SRS) Edition 2
Endpoint domain: Life impact
Endpoint subdomain: Social functioning