TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Change in Inflammatory Biomarkers
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Lipid and Glycemic Profiles
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: sensitivity of the dual-head system for detection of sub 10 mm breast lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Pulse-oximetry
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Numerical Rating Score (NRS) for pain score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Amount analgesic requirement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in T wave amplitude
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in T wave width
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: rate of locoregional control at one year
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of DLTs and treatment-emergent adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Clinically significant changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Adaptive Behavior
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Parent Empowerment
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: No Drug related Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Level of parents anxiety
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Pharmacokinetic profile of green tea catechins
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Intra-cortical pore volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change From Baseline in DAS-28 (CRP) at Week 6
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Global cognitive state
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Responder Rate: Percentage of Subjects with Serum Total Testosterone Levels Between 300 and 1050 ng/dL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change in pressure flow parameters
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in symptoms as measured by the BFLUTS questionnaire and Urgency Perception Scale
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Percentage of 1-Level Responders on the I-GAIS
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Tremor ratings
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Patients with at Least a 50% Reduction in CIPN Measurement Questions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Complete wound closure at week 12
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Quantitative quality of life assessment
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Qualitative quality of life assessment
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Heart Rate Variability analysis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 up to 12 Months After Dose 2
Endpoint domain: Adverse events/effects
Primary endpoint: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Mean Change in Liver Fibrosis of Corrected T1 (cT1) Mapping
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent of patients achieving PASI 50
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: scapulohumeral kinematics
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: muscle activities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PCR rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean number of total Gd-enhancing lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in beige adipose tissue
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in brown adipose tissue
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: all cause reoperation rate
Endpoint domain: Adverse events/effects
Primary endpoint: Level of microcirculation (Parameter Ingress)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Level of microcirculation (Parameter Ingressrate)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Progression-Free Survival at 16 Weeks
Endpoint domain: Mortality/survival
Primary endpoint: Sensitivity of sentinel lymph node detection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Blood Pressure Measurement Change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: FDG uptake in lung parenchyma
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Prevalence of women with a diagnosis of GDM
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Infant Behavioural Pain Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Percent Atheroma Volume (PAV)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Presence of active suicidal ideations
Endpoint domain: Adverse events/effects
Primary endpoint: Feasibility of endotracheal intubation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Anti-PRP Antibody Concentrations >= 1 mg/mL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Serum Bactericidal Activity (MenC) Titers >= 1:8
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Serum Bactericidal Activity (MenY) Titers >= 1:8
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Positive Affect
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in Negative Emotions
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change from Baseline in Pressure pain threshold at 10 minutes after the intervention
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from Baseline in Pressure pain threshold at 24 hours after the intervention
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from Baseline in Pressure pain threshold at one week after the intervention
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Caregiver age appropriate early childhood development knowledge
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Caregiver early childhood stimulation practices
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Father engagement with the child
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Responsive care
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Household environment risk
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Quality of CHWs counseling
Endpoint domain: Life impact
Endpoint subdomain: Delivery of care
Primary endpoint: Inventory of Life Quality in Children and Adolescents (ILC)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Multidimensional Health Locus of Control (MHLC)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in the Mean Daily Overactive Bladder-Symptom Composite Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Patients Remaining on Envarsus XR at 1 Year
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: IN-HOSPITAL MORTALITY
Endpoint domain: Mortality/survival
Primary endpoint: 30-day MORTALITY
Endpoint domain: Mortality/survival
Primary endpoint: 90-day MORTALITY
Endpoint domain: Mortality/survival
Primary endpoint: Change in heat pain threshold and tolerance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Immune response to measles vaccine
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Rate of 30-day unplanned readmission
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Change in patient's knowledge about total laryngectomy
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Body Iron Stores
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Net Change in Urinary Albumin-to-Creatinine Ratio (ACR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Level of Intra-abdominal Pressure (IAP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Classification Grade of Intra-abdominal Hypertension (IAH)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Adverse events (AEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Progression to Stage 3 AKI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Receipt of Renal Replacement Therapy (RRT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Proportion of patients failing to suppress viral load
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Mean change in HIV RNA measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Primary Patency of the Venous Stent at 12 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Freedom From Major Adverse Events (MAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Change in excess body weight
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Forearm Blood Flow
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 24h Urine Volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Area under the curve time zero - last (AUC t0-last)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the curve time zero - infinite (AUC t0-inf)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Constant of elimination (Ke)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Change From Baseline in the PANSS Negative Symptom Factor Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Patients With Persistent Hypoxia
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Need for Supplemental Oxygen After Discharge
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Sensitivity of the OCT for optical neuritis diagnosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Fluid distribution during early perioperative period
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Viral shedding in days since initial diagnosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of adverse events and severe adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Opioid and Benzodiazepine use
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Changes in Gut Microbiota
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Difference in total brain volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in total score on the NPI
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Functional Improvement (Barthel Index of Activities of Daily Living)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Clinical Safety Success
Endpoint domain: Adverse events/effects
Primary endpoint: Inflammation changes in gastrointestinal tract
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Faecal calprotectin (fC) levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Median Breast Feeding Score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Reduction in the number of draining perianal fistulas
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Penn Shoulder Score (PSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants Who Attended 13 or More Interventions
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Actual Smoking Status
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Score of the MADRS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: success of dexterity measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Modification of neutrophil activation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Theta source connectivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Local Skin Responses
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: AUEC(0-t)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Diabetic chronic renal disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Regional VT of [18F]PBR111
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of Refractive Predictability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of patients with febrile neutropenia (FN)
Endpoint domain: Adverse events/effects
Primary endpoint: Ovarian age change
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Subjects Without a Model 4196 Lead Related Complication
Endpoint domain: Adverse events/effects
Primary endpoint: Pacing Voltage Thresholds of Distal Tip Electrode
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pacing Voltage Threshold of Proximal Ring Electrode
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Management of hypertension
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Prevalence of delirium at two weeks after admission
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Activities of Daily Living (ADL) functional improvement two weeks after admission
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Full ADL functional recovery to pre-illness status three months after post-acute admission
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change in body mass index variation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Sustained resolution of heartburn
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Quantification of uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Increased survival of ICCs transplanted
Endpoint domain: Mortality/survival
Primary endpoint: Freedom From Procedure- or Device-related Mortality at 30 Days
Endpoint domain: Mortality/survival
Primary endpoint: Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: International RLS Rating scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Augmentation severity scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in depression measured with PHQ-9
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in depression measured with BDI-II
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of free-wall rupture
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of reperfusion arrhythmia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Prevalence of Fabry disease
Endpoint domain: Mortality/survival
Primary endpoint: Khalfa Hyperacusis Questionnaire
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Loudness discomfort threshold
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Curve (AUC) of Nicotine 2 mg
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Curve (AUC) of Nicotine 4 mg
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Concentration (Cmax) of Nicotine 2 mg
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Concentration (Cmax) of Nicotine 4 mg
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: FEV1 rate decline
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Menopause-related quality of life
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: oxyhemoglobin concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Total number of days hospitalized
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Optimal diagnostic MSOT thresholds for hemoglobin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Annual incidence rate of drowning
Endpoint domain: Mortality/survival
Primary endpoint: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Effectiveness - quality of life: Patient Reported Outcomes Measurement Information System (PROMIS-29)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Proportion of Participants with No Evidence of Progression (NEP)
Endpoint domain: Mortality/survival
Primary endpoint: Proportion of Participants with no evidence of progression and no active disease (NEPAD)
Endpoint domain: Mortality/survival
Primary endpoint: Proportion achieving body weight goal
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Overall response rate (ORR) at 3 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Overall response rate (ORR) at 6 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in the blood levels of different proteins that represent the host response
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: incidence of bilateral sacral blockade
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Islamic knowledge of living organ donation
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Change in living organ donation knowledge
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Efficacy of insulin needle
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in AOFAS score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improvement in back pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Unified Parkinson's Disease Rating Scale 3.0 (UPDRS 3.0)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Non-motor Symptom Scale (NMSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hand grip strength measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum tolerated dose (MTD) of metformin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Visual Analogous Scale (VAS) absolute change
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Treatment-Emergent Adverse Events [Safety and Tolerability]
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4
Endpoint domain: Adverse events/effects