TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Overall Response (Partial Response + Complete Response) for TNBC
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Overall Response (Partial Response + Complete Response) for HER2 + BC
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Number of Participants Experiencing at Least One Grade 3 to 5 Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Variation of the ANI
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Occludin level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Short-chain fatty acids production
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Subjective and perception pain (score 1 to 10 numerical)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Objective pain by algometer (units in kgf)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Functional test #2 - Five Times Sit-to-Stand Test (Unit time in seconds)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Incidence of sustained clearance of HCV (cure)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Proportion of patients with a platelet count ≥50×10^9/L at week 10
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Average Ultrasound Image Quality Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of patients receiving appropriate dosing of daptomycin
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Changes in word accuracy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cognitive functioning
Primary endpoint: Proportion of subjects without stenosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Persistence in PrEP care
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Arch width change
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent Change in Lipoprotein(a)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in the frequency of epileptiform discharges (number of spikes)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in the frequency of epileptiform discharges (number of seconds with spikes)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Incidence of chronic postsurgical pain (CPSP) at 6 months after surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of EV applications
Endpoint domain: Adverse events/effects
Primary endpoint: Number of individuals with positive Genexpert HIV Viral load assay
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Lumbar Spine Bone Mineral Density Z-score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Nasal Mucociliary Clearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Levels of iodine, cadmium and inorganic arsenic in macroalgae products
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Irisin blood levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean respiratory system resistance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Mean change in respiratory system resistance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Clinical Dementia Rating score (CDR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: General Practitioner Cognitive Assessment tool (GPCOG-TR)
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Bacteremia from an oral organism
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: cumulative incidence of emesis
Endpoint domain: Adverse events/effects
Primary endpoint: Rectus sheath hematoma formation
Endpoint domain: Adverse events/effects
Primary endpoint: Excessive bleeding from subrectus space
Endpoint domain: Adverse events/effects
Primary endpoint: concentration of cognitive function
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Composite unfavorable tuberculosis treatment outcome
Endpoint domain: Adverse events/effects
Primary endpoint: Induced immunomodulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Visualization of the vocal cords
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Freedom from Serious Adverse Events and Serious Adverse Device Effects
Endpoint domain: Adverse events/effects
Primary endpoint: Successful crossing, introduction and deployment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Standard uptake value (SUV) max at 60 minutes post-injection
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of abacillated patients
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Measurement variability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cardiac index measures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Continuous cardiac output measures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Mean score difference in PHQ-9 score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Mean score difference in GAD-7 score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: cardio respiratory endurance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Nutritional quality of porridge
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Proportion of patients with microbiological eradication
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Risk of loneliness
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Self reported physical activity levels and mental wellbeing
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Percent of Participants Enrolled Relative to Approached
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Participant Drop out Rate
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Post-Intervention Virtual Reality Sickness Questionnaire (VRSQ) Score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Efficacy evaluation indexes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of Participants With TEAEs
Endpoint domain: Adverse events/effects
Primary endpoint: Mean difference in Gastrojejunal Anastomosis size
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Five Dimensional Mindfulness Scale Scores
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Total pathological complete response (tpCR) rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Disimpaction efficacy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Caudal block success
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in local metabolomic profile after treadmill exercise
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in local inflammatory profile after treadmill exercise
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in dyspnea sensation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of on-demand treatment improvement for newly occurring bleeding events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Activity recovery
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Ovarian follicle size
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Semen function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Change from Baseline in Inflammatory lesion counts
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: early detection of preeclampsia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Mental health condition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Beat-to-beat Blood Pressure Variability
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: regional lung ventilation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: BARC type 2-5 bleeding episodes
Endpoint domain: Adverse events/effects
Primary endpoint: Organ Perfusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Plaque quantification
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Quantification of stenosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Characterization of plaque to evaluate for high-risk features
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Incidence of LIT
Endpoint domain: Adverse events/effects
Primary endpoint: Major Complications of the Target Limb Access Site Within 30 Days
Endpoint domain: Adverse events/effects
Primary endpoint: Change in cough frequency per hour
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Phoneme identification in noise
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cardiac hypertrophy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Laboratory enzyme levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Knowledge Acquisition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical Skills Performance Checklist - Airway Management
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Clinical Skills Performance Checklist - Fracture Management
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Peak plasma concentration (Cmax) of S-warfarin and R-warfarin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the plasma concentration versus time curve (AUC) of S-warfarin and R-warfarin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peak plasma concentration (Cmax) of DBPR108
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the plasma concentration versus time curve (AUC) of DBPR108
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peak plasma concentration (Cmax) of Digoxin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: percentage of patients that complete treatment
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Median number of days for platelet count to reach 100×10^9/L or increase by 50×10^9/L
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Peripheral Index (PI) in low cardiac output
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Cerebral NIRS in low cardiac output
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: post-operative abdominal mean drainage duration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change from baseline in cardiac enzyme levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change from baseline in systolic and diastolic blood pressures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Prevalence of hyperekplexia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: CUD/SUD Symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Neural Reward Anticipation - fMRI response to reward anticipation (MID)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Computationally-Derived Behavioral Reward Learning Rate - Learning rate (alpha parameter)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Dry eye incidence after cataract surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improvement in Movement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Participants With Adverse Events (AE)
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of Participants With Serious Adverse Events (SAE)
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of Participants With Clinically Significant laboratory tests, ECG, physical examination, vital signs
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Expression level of lncRNA UPK1A-AS1 and/or UNC5B-AS1
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Target miRNAs expression levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Target proteins level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: General Comfort Scale Short Form
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Uterine tone upon discharge from PACU
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: COVID-19 Symptoms, Diagnoses, and Testing Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rates of Adverse events according to CTCAE 5.0
Endpoint domain: Adverse events/effects
Primary endpoint: 4-week objective response rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Stop Signal Task
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Fear Extinction Recall Task
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Sequential Spaceship Task
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Severity of Sjögren disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Force of contraction of pelvic floor muscles
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Incidence of Sleep Disorders
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Haemoglobin A1c (HbA1c) level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Proportion of participants achieving HbA1c less than (<) 7.0%
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Proportion of NASH treatment modalities
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: NASH Knowledge, Belief and Practice Questionnaire responses
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change from baseline in BCVA measured by the ETDRS letter score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: atrial fibrillation (AF) recurrence rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: glucose serum
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: TTG-IgA
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Maximum tolerated dose (MTD) for tegavivint
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Determination of the recommended phase II dose (RP2D) of tegavivint
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: satisfaction with smart visit app
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: use of smart visit app
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Frequency of high-intensity drinking
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of blackouts
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of M3T for endometrium image capture
Endpoint domain: Adverse events/effects
Primary endpoint: Usability of M3T for endometrium image capture
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Platelet-leukocytes aggregates quantification
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Number of residents recruited from participating homes
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Number of motivational interviewing sessions attended
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Number of home-based activity sessions attended
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: 3D kinematic measurements lower limb
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: 3D kinematic measurements upper limb
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Time to first occurrence of cardiovascular death or hospitalization due to heart failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Percentage of Participants with complete TMA response (cTMAr)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants Experiencing Adverse Events Leading to Death
Endpoint domain: Adverse events/effects
Primary endpoint: Cerebral perfusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Cerebral autoregulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Cerebral resting blood flow
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Patient Health Questionnaire Somatic-Anxiety-Depression
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Percentage of Participants Who Achieve Complete Remission
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of overt HE
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Retention of Restorative Material
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fracture of Restorative Material
Endpoint domain: Adverse events/effects
Primary endpoint: Uterine vessels injury
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: T-cell receptor (TCR) profiles
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: T-cell receptor (TCR) clonality
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: T-cell receptor (TCR) diversity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Faecal weight
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Target engagement of gaboxadol treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Number of hypertension patients who decide to join in a clinical study
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Rate of patients who remain in a hypertension clinical study to completion
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Percentage Change In Lactate Dehydrogenase (LDH)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cell kill
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: IC50 (inhibitory concentration)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: HBsAg conversion rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Concentration of ofatumumab in breast milk
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency and severity of adverse events of special interest
Endpoint domain: Adverse events/effects
Primary endpoint: Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF])
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes