TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Fat mass weight
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Fat mass percentage
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Six and eight skinfold sums
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Post intervention analgesic effect
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Combined occurrence of cardiac events
Endpoint domain: Mortality/survival
Primary endpoint: Change in sinus cycle length
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Anterograde atrioventricular node Wenckebach cycle length
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Perception of Stress Questionnaire (PSQ)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Body composition (fat and fat free mass)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Abdominal fat distribution using abdominal MRI
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: loudness
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: OHIP score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: clinical attachment level measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Knowledge Scores at 1 Week
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Attitudes Scores at 1 Week
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Self-Efficacy to Communicate Scores at 1 Week
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of patients with a deleterious mutation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: feasibility of cardiac screening program
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Dexmedetomidine clearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of patients with chronic pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Glycated hemoglobin (Hb A1c) change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Excess Weight Loss change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: sublingual tonometric PCO2 - arterial PCO2
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: sinus symptoms scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the factor IX activity-time curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Time required for wound bed preparation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Percentage of Participants With Systolic Blood Pressure ≥180 mmHg
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
Endpoint domain: Physiological/clinical
Endpoint subdomain: Liver outcomes
Primary endpoint: Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline
Endpoint domain: Physiological/clinical
Endpoint subdomain: Liver outcomes
Primary endpoint: Percentage of Participants With Suicidality
Endpoint domain: Adverse events/effects
Primary endpoint: Exposure to information on relationships
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Knowledge of condoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Quality of co-parenting relationship
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Proportion of successfully decolonized patients
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Safety of VELCADE
Endpoint domain: Adverse events/effects
Primary endpoint: effects on oxygenation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: effects on respiratory mechanics
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Systolic Blood Pressure, Change From Baseline to End of Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Diastolic Blood Pressure, Change From Baseline to End of Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Pulse, Change From Baseline to End of Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: AUC Norethindrone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Virological clearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Remission of fever
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Remission of cough
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Deviation from target
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Recovery of Coagulation Factors
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Recovery of Haemostatic Parameters
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change in Dysfunctional Attitude Scale score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in mental illness symptoms (anxiety, depression)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in concentration of circulating proinflammatory cytokines
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in cardiorespiratory fitness
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Major Cytogenetic Response Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Substance use
Endpoint domain: Adverse events/effects
Primary endpoint: Reduction in Seizure Frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Number of Participants Continuing Study Medication Over Time
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Mean Percent Change in Triglycerides
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Massachusetts General Hospital Hairpulling Scale (MGH-HS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time from needle biopsy to final diagnosis
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Change in nutrient intakes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Efficacy of Pascallerg
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tolerability of Pascallerg
Endpoint domain: Adverse events/effects
Primary endpoint: Constance and Oxford Scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Occurrence of acute otitis media
Endpoint domain: Adverse events/effects
Primary endpoint: Levonorgestrel Area Under the Curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Holotranscobalamin (HTC) levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Changes in levels of emotional self-awareness
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Success rate of unsedated colonoscopy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change in the proportion of patients with haemoglobin within the target range
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Proportion of monocytic sub-population(s)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Composite of major adverse cardiac or cerebrovascular events (MACCE)
Endpoint domain: Adverse events/effects
Primary endpoint: safety and tolerability profile
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Depression, Anxiety and Stress
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Pneumococcal serotype-specific IgG geometric mean concentration (GMC) ratios
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Postural Sway
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Vascular Endothelial Growth Factor (VEGF) Levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Grade I and II rupture during delivery
Endpoint domain: Adverse events/effects
Primary endpoint: number of complete remissions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Mean Number of Standard Drinks Per Drinking Day
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in gastrointestinal symptom severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Incidence of CSD
Endpoint domain: Mortality/survival
Primary endpoint: Fear of Recurrence level
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: CVD risk (10 year estimated risk)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Meaning in life
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: exposure and pharmacokinetics of NGMN, NG, and EE
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Comparability of atazanavir exposure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Trough levels of total immunoglobulin G (IgG)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: inflammatory tear cytokine concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Renal Clearance of adefovir
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change from baseline in temperature at the fingers
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: FEV1 (Forced Expiratory volume in 1 second)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: EC50 of TRAP-6 in terms of surface CD62P expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: EC50 of insulin in terms of intraplatelet VASP-phosphorylation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: remodelling indexes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: wall stress index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: fibrosis of systemic RV measured by MRI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Glucose and insulin homeostasis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Antibody Response D28
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Copenhagen Burnout Inventory (CBI)
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Number of Participants With Confirmation of Failure Criteria
Endpoint domain: Adverse events/effects
Primary endpoint: Cellular immune system profiling
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Eating Disorder Symptom Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Initiation of Smoking Cessation Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants Achieving a 75% Improvement in PASI Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: 1-year transplant event-free survival
Endpoint domain: Mortality/survival
Primary endpoint: Chronic insomnia severity
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Femoro-tibial Kinematics: Translation and Lift-off for Gait
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Percentage of patients with clinical improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ERG a and b implicit time and latency
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to SARS-CoV-2 negative test
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Total percent acid exposure time
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Positive Breath test
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Malabsorption
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Intolerance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Early Virologic Response (EVR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: lacritin levels in human tears
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Oxygen consumption (VO2)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Monitoring for metabolic issues related to treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Monitoring tests for hyperlipidemia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Monitoring for signs and symptoms of hyperglycemia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Monitoring blood glucose levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Monitoring weight at treatment initiation and regularly thereafter
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Response according to ACR20 classification
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cardiac conduction intervals
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Changes in intestinal transit
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Change in perceived stress
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in Kinase Expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with suicide attempt or death by suicide
Endpoint domain: Mortality/survival
Primary endpoint: Change from baseline in vascular reactivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: OCT-based intimal injury score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 1-year Survival
Endpoint domain: Mortality/survival
Primary endpoint: Gastrointestinal-mediated glucose disposal (GIGD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: plasma Glucagon
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change from Baseline in Total Personal and Social Performance (PSP) Score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Change in patient activation scores
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in self-management
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Opioid pain medicine usage
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: psychoactive drug misuse
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Diurnal IOP
Endpoint domain: Physiological/clinical
Endpoint subdomain: Ocular outcomes
Primary endpoint: Itching intensity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Overall child development - PRIDI score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Change in DP ARF marginal peak displacement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Efficiency of biopsies
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Time To Treatment Failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with dose-limiting toxicities
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of participants with adverse events (AEs) and serious AEs (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Mean minimal and maximal platelet count
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Lipid levels in plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Stimulant effects of alcohol
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complete aneurysm occlusion without > 50% parent artery stenosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Percentage of time with BS-11 pain score of ≤ 4
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Average Pain Intensity Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total morphine dose
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: As needed (pro re nata; PRN) medication
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Target concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Average reduction in pain severity score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Intraocular Pressure Reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Atrial fibrillation recurrence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Fibrinolytic balance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of ischemia as judged by ST segment analysis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Cocaine Abstinence
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Time needed for cervical ripening
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Time to first appropriate therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to first inappropriate therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Heart-failure related adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Mean change in best-corrected ETDRS visual acuity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with gastrointestinal toxicity >/= G2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Number of participants with genitourinary toxicity >/= G2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change from Baseline in Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Rate of moderate and severe exacerbations per year
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from Baseline in COPD assessment test (CAT) score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Food and energy intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Incidence of Dose Limiting Toxicity (DLTs)
Endpoint domain: Adverse events/effects