TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Change of glucose level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change of insulin level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change of glucagon level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change From Baseline in Mean Conjunctival Hyperemia Scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: change in Tenosynovitis pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: change in Tenosynovitis tenderness
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: changes in ultrasound images of the Tenosynovitis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Changes in plasma osmolality
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Optical coherence tomography
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fluorescein angiography
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Identification of DMD biomarker/s
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Patients' adherence to unit dose packaging devices
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change in the Sum of Longest Diameters of Baseline Target Nodules
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Prevalence of Fabry disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC0-12h of intracellular ZDV-TP
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC0-12h of carbovir-TP
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Dysarthria severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Number of participants who relapse
Endpoint domain: Adverse events/effects
Primary endpoint: Narcotic Use
Endpoint domain: Adverse events/effects
Primary endpoint: Neurologic Impairment at 12 Months (Motor Scores)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Neurologic Impairment at 12 Months (Mental Scores)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Number of participants alive
Endpoint domain: Mortality/survival
Primary endpoint: Late postoperative combined endpoint of 4 Major Adverse Cardiovascular Events (MACE) complications
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of occurrence of conjunctival hyperaemia
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Nutrition Intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Toxicity profile of ET190L1 ARTEMIS™ T-cell treatment
Endpoint domain: Adverse events/effects
Primary endpoint: Duration of in vivo engraftment of ET190L1 ARTEMIS™ T cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in gadolinium chelate enhancement on DCE-MRI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Fasting circulating levels of HbA1c
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of Participants With Treatment-Emergent AEs (TEAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Virologic Failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Ocular Surface Disease Index questionnaire
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Schirmer test with anesthesia
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to the presence of fusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Approximation accuracy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline in left ventricular ejection fraction (LVEF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in rate of myocardial oxygen consumption
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: MTD/RP2D determination
Endpoint domain: Adverse events/effects
Primary endpoint: Visible improvement in treated area
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: safety of sugammadex
Endpoint domain: Adverse events/effects
Primary endpoint: Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: American Shoulder and Elbow Surgeon's Score (ASES)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Shoulders With Radiographic Success
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of biopsy proven acute rejection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Systemic embolism
Endpoint domain: Mortality/survival
Primary endpoint: Number of whole-body bone lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Number of bone lesions within defined skeletal areas
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Early castration rates
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: FEV1 AUC0-12h normalised by time
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: SVR12 (HCV RNA <LLOQ)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in serum glucose levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Variation in lipid profile
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: fMRI response to taste and smell stimuli
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change From Baseline in TWSTRS Total Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum concentration of cefepime and AAI101 in the lung
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Severe irritation (Grade 3 or 4)
Endpoint domain: Adverse events/effects
Primary endpoint: Initial total vessel density
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of total vessel density
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sustained Virologic Response at 12 weeks post-treatment (SVR 12)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prevalence of obstructive sleep apnea
Endpoint domain: Physiological/clinical
Endpoint subdomain: Sleep
Primary endpoint: Conversion from NRDS to ARDS
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Adherence to tobacco use treatment guidelines
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Reasoning score change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Attention score change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Speed of processing score change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Working memory score change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Verbal learning and memory score change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Visual learning and memory score change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Total Number of Serious Adverse Events (SAE) Through Study Day 14
Endpoint domain: Adverse events/effects
Primary endpoint: Median Time to Hospital Discharge (or Discharge Equivalent) Following First Dose of CCP
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Change in Lean Body Mass
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fear of Birth Scale
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Wijma Delivery Expectancy/Experience Questionnaire
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Acceptance of candidate formulations
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Bioavailability index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Gene expression index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of early-onset serious adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Acute success and chronic freedom from AF, AFL or AT
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Gene Expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Glucose tolerance during pregnancy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Absence of nasal regurgitation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Fluoroscopy time measured during percutaneous nephrolithotomy (PCNL)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change in the volume of stone before and after PCNL surgery (Stone clearance)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Patients Unable to Proceed to Transplantation
Endpoint domain: Mortality/survival
Primary endpoint: Female Sexual Function Index
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Feeling of safety
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Cmax, Maximum observed serum concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC, Area under the plasma concentration versus time curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with adverse events that are related to treatment
Endpoint domain: Adverse events/effects
Primary endpoint: Decreased craving
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Safety of intrathecal α-L-iduronidase administration
Endpoint domain: Adverse events/effects
Primary endpoint: Expulsion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Intubation Time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Late Luminal Loss
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Patients Maintaining Spontaneous Erectile Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Full recovery one day after injury
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of cells showing repair, remodeling or regeneration of the epithelium
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Levels of alpha-synuclein in blood plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: White-matter integrity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Performance on tests of attention
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Number of Participants With no Emesis and no Rescue Therapy
Endpoint domain: Adverse events/effects
Primary endpoint: Quality of Life: SF-12 Physical Component Summary (PCS)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Quality of Life: SF-12 Mental Component Summary (MCS)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Quality of Life: EQ-5D
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Barrier resolution
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Navigation and care
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Maximum plasma concentration (Cmax) of abiraterone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the plasma concentration-time curve (AUC) of abiraterone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to reach the maximum plasma concentration (tmax) of abiraterone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: length of hypoxemia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: DSM-IV diagnoses of SUD and PTSD
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Readiness for decannulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Dose-Limiting Toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: Pulse Pressure Variation (PPV)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Pleth Variability Index (PVI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Mean C/D Ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinically relevant worsening of visual function
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of wet nights
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: The Number of Participants Experiencing Adverse Events (AEs)
Endpoint domain: Adverse events/effects
Primary endpoint: The Number of Participants Experiencing Serious Adverse Events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: The Number of Participants Experiencing Adverse Events Resulting in Death
Endpoint domain: Adverse events/effects
Primary endpoint: Visual Analog Scale (PAIN)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ROM of Cervical spine (Flexion)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: NDI (neck Disability Index)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: change in FI2S score
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Percentage of Participants Achieving 90% Improvement in PASI Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Ertapenem Transmembrane Clearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: postprandial fat oxidation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean Ex-vivo Total Lipid Uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Stanford Sleepiness Scale
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Protein Balance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Skeletal Muscle Mass
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complete Molecular Remission
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in total energy expenditure (TEE)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in resting energy expenditure (REE)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in physical activity energy expenditure (PAEE)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Diagnostic yield of transbronchial lung biopsy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Evaluation of the test expressed as percentage positive in samples
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Neurocognitive measures of sustained attention and memory
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Rate of leukoencephalopathy and hemosiderin deposits on quantitative MRI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Rate of neurologic symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: ADAS-Cog score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: hospitalization for nonfatal cardiovascular events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Visual analogue scale (VAS)-pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Joint range of motion (ROM)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of Patients Receiving Complete Induction Course
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Brain activation networks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Timeliness of immunization
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Safety including adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Clinically significant changes in laboratory results
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: ECG and vital signs
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Shoulder Pain and disability index (SPADI)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Performance Time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the amount of students accomplishing their education within 3 years
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Change in the level of absence for students
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Change in grades (maths, norwegian, english)
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Serum Albumin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: IL-6
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction in iNKT Cell Activation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Decrease in the number of COP exacerbations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Comprehension
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Psychological impact
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Percentage of Participants With a Complete Response (CR) or CR With Incomplete Blood Count Recovery (CRi) or Morphologic Leukemia Free State (MLFS) or Partial Response (PR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Decrease in Liver Stiffness
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Occurrence of greater or equal grade 3 toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: Pulmonary microthrombosis assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Proportion of patients with biochemical and histological remission
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of patients who experience Cannabidiol related adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of patients with flare up of hepatitis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Waist to hip ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Occurrence and incidence of malignancies
Endpoint domain: Adverse events/effects
Primary endpoint: Occurrence and incidence of leg ulcers
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Occurrence and incidence of male fertility impairment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Occurrence and incidence of serious unexpected AEs causally related to Siklos®
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of dose limiting toxicity (DLT)
Endpoint domain: Adverse events/effects