TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Average clinical development of target lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Adverse events associated with CD19t T-APC product infusions
Endpoint domain: Adverse events/effects
Primary endpoint: Urinary catecholamines
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Expression levels of markers of the FASN/AMPK pathway
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Peri-device leak rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters
Endpoint domain: Adverse events/effects
Primary endpoint: Concentration of Cabotegravir in Plasma at the End of the Dosing Interval (Ctau)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Accuracy of SpotOn
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: locoregional recurrence-free
Endpoint domain: Mortality/survival
Primary endpoint: Usage of Morphine
Endpoint domain: Adverse events/effects
Primary endpoint: Participant's acceptability of study design
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Willingness to enter study
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: reduction in extravascular lung water
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change in insomnia severity
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Change in subjective sleep quality
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Maximum Tolerated Dose (MTD) of Pictilisib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Recommended Phase II Dose (RP2D) of Pictilisib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cerebral Desaturation Event
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Exhaled nitric oxide levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: cytometry time of flight (CyTOF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ECG ST monitoring feasibility
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in myocardial ischemic injury markers (c-reactive protein and Troponin I)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Maximum tolerated dose (MTD) of vinflunine and pemetrexed disodium
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Maximum tolerated dose (MTD) of vinflunine and continuously dosed erlotinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Maximum tolerated dose (MTD) of vinflunine and intermittently dosed erlotinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Persistence of Resistance-Associated Variants
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Phenotypic Resistance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction in Grade 3/4 Neutropenia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: outcome of the surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Seven-day point prevalence abstinence
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Development of Bullous pemphigoid
Endpoint domain: Adverse events/effects
Primary endpoint: Inflammation markers
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: PPG individual peak detection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: PPG and Holter ECG signals correlation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Pain in the first 12 postoperative hours
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change in adherence to home exercises
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change from baseline in Young Mania Rating Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of dropout (treatment discontinuation)
Endpoint domain: Adverse events/effects
Primary endpoint: Time to attending chart completion
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Response Rate During Randomized Phase
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Total Improvement Score (TIS) During Randomized Phase
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: PASI (Psoriasis Area Severity Index) score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: PGA (Physician's Global Assessment) score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Adverse Events of Daratumumab
Endpoint domain: Adverse events/effects
Primary endpoint: psychophysiological difference score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: fNIRS rlIFG difference score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Social cognitive measures
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Pharmacokinetics of AZD1981 and Midazolam
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of Malunion
Endpoint domain: Adverse events/effects
Primary endpoint: personal efficacy
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in renin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Brief Smell Identification Test (BSIT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline in mean hemoglobin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Proportion of participants with peripheral neuropathy
Endpoint domain: Adverse events/effects
Primary endpoint: Cervical Motor Control
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion
Endpoint domain: Adverse events/effects
Primary endpoint: Frequency, severity, and type of adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Clinical Disease Activity Index (CDAI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mental Health Service Use
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Incidence of red blood cell transfusions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Incidence of Bacteriemia
Endpoint domain: Adverse events/effects
Primary endpoint: Changes on the salivary pH
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes on the salivary Streptococcus mutans counts
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Changes on the salivary flow rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Left ventricular volumes and LVEF
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of Students Who Initiated the HPV Vaccine Series
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Number of Students Who Completed HPV Vaccination
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: composite event of death, myocardial infarction, or stroke
Endpoint domain: Mortality/survival
Primary endpoint: Incidence of unexpected events related to the research product
Endpoint domain: Adverse events/effects
Primary endpoint: Positive outcome rates
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Incidence of acute rejection Banff grade borderline or higher
Endpoint domain: Adverse events/effects
Primary endpoint: Percent of infants breastfed exclusively
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Daily volume of formula supplement received by mixed feeders
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants Without a Disease Activity Flare
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Metavir Fibrosis Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Liver outcomes
Primary endpoint: Radiological lung expansion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Time to progression of HIV disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Brain network activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Children's Depression Inventory (CDI)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Paediatric Quality of Life Inventory (PedsQL)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Survival Duration Without Disease Progression
Endpoint domain: Mortality/survival
Primary endpoint: Blood supply condition
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change in mortality rate of neonatal sepsis in preterm neonate
Endpoint domain: Mortality/survival
Primary endpoint: Number of Preterm Neonates who will have long term Complication after one month of regular use of Lactoferrin
Endpoint domain: Adverse events/effects
Primary endpoint: Change in WAB-AQ
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Total morphine milligram equivalents administered
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Scored Patient-Generated Subjective Global Assessment
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: SOFA score ≥ 2
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Aerobic capacity (V02 max)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Participant-reported most important attribute
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of Participants With Potentially Clinically Significant Liver Enzyme Abnormalities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants With Potentially Clinically ECG Abnormalities
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pelvic floor muscles strength
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Pelvic floor muscles endurance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change in Hemoglobin A1c (A1C) at 40 Weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in Hemoglobin A1c (A1C) at 12 Weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of Infants Who Took All Feeds by Mouth (Responders)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ml/kg/d Increase Over 7d During taVNS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Neuroplasticity as Measured by the Change in White Matter Tract Integrity Via Fractional Anisotropy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Cmax of plasma budesonide concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cmax of plasma formoterol concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUCt of plasma budesonide concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUCt of plasma formoterol concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sensitivity for locoregional disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ratio of the stent strut
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Time interval between surgical therapy for recurrent respiratory papillomatosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Plasma concentration of Apixaban and Atenolol
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cumulative incidence of skeletal events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Proper endotracheal tube placement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Number of Patients With Persistent Atrial Fibrillation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Delivery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Composite measure of preoperative feasibility and safety
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction of >50% on Numerical Rating Scale (NRS-11)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence and severity of Injection Site Reaction (ISR)
Endpoint domain: Adverse events/effects
Primary endpoint: Visual Analog Scale (VAS) Score for Injection Site Pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Effective anti-HB levels >150 IU/ML
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Patients Who Demonstrated Treatment Effectiveness Based on PSA Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Asthma Control Test for children (cACT™)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 IU/mL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Number of participants with anti-Tetanus antibody concentrations ≥ 0.1 IU/mL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Number of participants with ≥ 4 fold increase in anti-PT and anti-FHA antibody concentrations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN)
Endpoint domain: Adverse events/effects
Primary endpoint: anterior tilt angle of the tibia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: LUTS onset
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Arterial Dilation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in MRI-Proton Density Fat Fraction (MRI-PDFF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Clinical malaria episodes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Nocturnal Sleep Length
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Rate of pathologic response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Malondialdehyde (MDA) level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: recrudescence rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: No hematological, hepatic or renal toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Hamilton Depression Scale-24
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change from Baseline in CDI
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Migraine Frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Migraine Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Optical signal from maternal and fetal tissues
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of intrusive memories of traumatic event(s)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Feasibility of preparing lethally irradiated autologous glioma cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of subcutaneous and intradermal injection of irradiated autologous malignant glioma cells
Endpoint domain: Adverse events/effects
Primary endpoint: Biological activity of vaccination therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Postoperative pancreatic fistula (POPF) rate
Endpoint domain: Adverse events/effects
Primary endpoint: Complete success
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Proportion of pregnant women vaccinated against pertussis
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Proportion of pregnant women who consider pertussis as serious risk for infant
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Proportion of pregnant women who consider pertussis vaccination during pregnancy as safe
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Safety and tolerability profile of nilotinib
Endpoint domain: Adverse events/effects
Primary endpoint: Efficacy of nilotinib 400 mg BID
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Relief from dry mouth
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of bed wetting
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: cough incidence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Vastus medialis Oblique (VMO) Thickness
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Response (Stable Disease or Objective Response)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: lower limbs strength
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: dual task walking
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Relative bioavailability (Cmax/AUC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of patients with protocol-specified HLA subtype
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Frequency of patients with expression of analyzed tumor antigen targets
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Re-consultation
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: N-cadherin and vimentin expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total Harris Hip Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Firmicutes/Bacteroides ratio in feces
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: continuous abstinence rate for smoking
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Lumbar Spine Bone Mineral Density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in Total Hip Bone Mineral Density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in Femoral Neck Bone Mineral Density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in 1/3 Forearm Bone Mineral Density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Improvement in the Severity of Asthma
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety and tolerability of TOL-463 gel and ovules
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of Clavien-Dindo Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Total International Prostate Symptom Score (IPSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the curve (AUC) (0-t)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes