TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Area Under the Concentration-time Curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to Reach Maximum Observed Plasma Concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of genetic polymorphisms related to adenosine and methionine metabolism
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Levels of adenosine and methionine cycle nutritional and metabolic determinants
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: mLDL-C change rate (%)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Percentage of Heartburn-Free 24-Hour Periods
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Extent of α-hydroxylation of NNN
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of recurrence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Length of Hospitalization
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Sequential Organ Failure Assessment (SOFA) Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Patients With Any Adverse Events and Serious Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: MRD response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Brain Structure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Proportion of subjects with PSA ≤ 0.2 ng/mL
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Usability of Eeva System
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Reports of device malfunctions
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of men on active surveillance without treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improvement of Body mass index
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Incidence of Grade 3 or Worse Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: antibiotic prescription rate
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Number of participants with early treatment cessation
Endpoint domain: Mortality/survival
Primary endpoint: Progression-free survival (PFS-R2)
Endpoint domain: Mortality/survival
Primary endpoint: plasma uric acid
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Fractional uric acid excretion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Elimination half-life (t 1/2)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total RNA in muscle tissue
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with adverse reactions related to infusion
Endpoint domain: Adverse events/effects
Primary endpoint: Major Wound Healing Complications
Endpoint domain: Adverse events/effects
Primary endpoint: Minor Wound Healing Complications
Endpoint domain: Adverse events/effects
Primary endpoint: Renal Safety Measures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change in urine output
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Proportion of subjects with complete or partial response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 101-point verbal rating scale (VRS)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change of blood pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sweat Chloride at 6 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sweat Chloride at 30 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Forced expiratory volume at one second (FEV1) at 6 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Forced expiratory volume at one second (FEV1) at 30 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Adjudicated symptomatic venous thromboembolic events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: First puncture success rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total survival Time
Endpoint domain: Mortality/survival
Primary endpoint: Risk of preterm birth incidence
Endpoint domain: Mortality/survival
Primary endpoint: Risk of low birth weight incidence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Risk of small for gestational age incidence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Risk of neonatal intensive care unit (NICU) admission incidence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Percent Change in Plasma VEGF
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: findings compared across investigation modes
Endpoint domain: General outcomes
Primary endpoint: Maximum Increase of Troponin at 24 Hours
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Toronto Active Movement Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prescribing decision
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: percentage of adequate endometrial biopsies utilizing sonohysterography
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: percentage of adequate endometrial biopsies collected without sonohysterography
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Combined endpoint of major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
Endpoint domain: Mortality/survival
Primary endpoint: Index of adverse vessel wall features by OCT
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Central nervous system composite endpoint event
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Hyoid bone-skin distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Epiglottis-skin distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Thyroid isthmus-skin distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Vocal cord-skin distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of related serious adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Post-operative urinary retention requiring re-catheterisation
Endpoint domain: Adverse events/effects
Primary endpoint: Serum TARC level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Initiation of Losartan Therapy
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: specificity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: negative predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to bacterial eradication
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Plasma unconjugated estrone Cmax
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Plasma unconjugated estrone AUCall
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Plasma unconjugated equilin Cmax
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Plasma unconjugated equilin AUCall
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Number of subjects with adrenal suppression
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Homologous recombination deficiency (HRD) score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Proportion of Subjects Achieving Partial Response, Stable Disease or Progressive Disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Poor pregnancy outcomes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Percent agreement with pilot sensor and current standard of vital signs monitoring
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: frequency of reticulocytes PIG-A mutated
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: frequency of binucleated cell micronuclei
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Severity of coronary artery stenosis (Gensini Score)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in tau deposition as measured by 18F-AV-1451 SUVR
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Preparation for decision making scale
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Total score of visualization parameters
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: BKV viral load
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: AUC from time zero to infinity (AUC0-∞)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC from time zero to the last quantifiable concentration (AUC0-t)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Stage distribution of HIV-seropositive patients
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency and intensity of physical activity
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Prevalence of acute (bleed-related) pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prevalence of chronic (arthritic) pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Mean Daytime QT Interval (QTcF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Quantity of EEG abnormalities detected
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: change in social cognition scores
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: changes in electrolyte levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: QT interval on electrocardiography
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from Baseline in videofluoroscopic swallowing study (VFSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of ventral hernia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pain Visual Analogue Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complications post procedure
Endpoint domain: Adverse events/effects
Primary endpoint: Nocturia episodes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent Diameter Stenosis of the Treated Renal Artery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Readiness for Discharge
Endpoint domain: Life impact
Endpoint subdomain: Delivery of care
Primary endpoint: Calculated creatinine clearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Sensitivity and Specificity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Stool-based biomarkers associated with genetic and epigenetic alterations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Blood-based biomarkers associated with genetic and epigenetic alterations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Caregiver Burden
Endpoint domain: Resource use
Endpoint subdomain: Societal/carer burden
Primary endpoint: Functional Well-Being
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Personal Health Questionnaire Depression Scale
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Heart Rate Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Perceived Effort
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change on MRI binary criterion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Successful Decongestion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the 4-week total number of satisfying sexual events
Endpoint domain: Life impact
Endpoint subdomain: Sexual functioning
Primary endpoint: Change in the mean ISED desire score
Endpoint domain: Life impact
Endpoint subdomain: Sexual functioning
Primary endpoint: Cesarean delivery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Excitability of spinal neurons
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Use of chemotherapy
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Time for first requirement of rescue analgesia
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Dose Limiting Toxicity (DLT)
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of suspected adverse reaction (SAR)
Endpoint domain: Adverse events/effects
Primary endpoint: time and percentage of sitting achievement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: time and percentage of standing achievement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: time and percentage of walking achievement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Modified Rankin Score (mRS)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: NIHSS response
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Social Participation
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Two dimensional gait analysis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Dynamic gait index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Individuation of DNA of intracellular agents
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: VRS Pain Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Mini-BESTest Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent Change From Baseline in Maximum Target-to-background Ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Maximum tolerated dose (MTD) of intraperitoneal oxaliplatin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of treatment emergent adverse events per subject
Endpoint domain: Adverse events/effects
Primary endpoint: Number of subjects with anti-AMG 761 antibodies
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with treatment related adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: BOLD-activity changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Social Phobia Inventory (SPIN)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Social Participation & Satisfaction Questionnaire (SPSQ)
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Plasma concentration of digoxin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Urine concentration of digoxin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Neurocognitive composite score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Change in Bone Mineral Density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Net days with scheduled activity
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: HIF-1a expression levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline in 24-hour urine glucose excretion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change from baseline in the area under the plasma glucose concentration-time curve (AUC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change from baseline in the area under the plasma insulin concentration-time curve (AUC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Coronary artery calcium prevalence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: change in right ventricular (RV) enddiastolic diameter basal
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: change in RV enddiastolic diameter mid-cavitiy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: change in RV enddiastolic diameter longitudinal
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Five Facet Mindfulness Questionnaire
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Beck Depression Inventory - 2
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Total consumption of morphine or morphine-equivalent
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Visual analogical scale (VAS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Algometry
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sport activity pain perception
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Dimensional scoliosis correction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peak Hematocrit
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Ureteral stent related pain and lower urinary tract symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Leg Collateral Count (Via Contrast Enhanced-MR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Peak Hyperemic Popliteal Flow (Phase Contrast MRA)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Capillary Perfusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Percentage of patients with target BP
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Rate of blood patch use
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Protective efficacy against clinical malaria
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Number of Participants With Serious TEAEs (STEAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Collection of blood and tissue
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Percent Change in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Grade >=3 Infusion-Related Reactions (IRRs)
Endpoint domain: Adverse events/effects