TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Quality of colonoscopy preparations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Stage Shift Index (SSI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Sleep
Primary endpoint: SLEDAI-2K score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Outcome of repositioning of humerus fractures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change in subscale of PANSS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline in slow vital capacity (SVC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Perception of need for antiepileptic treatment
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Concerns about potential adverse effects of antiepileptic drugs
Endpoint domain: Adverse events/effects
Primary endpoint: Change in saturation of oxygen in the blood
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Urinary catheter awareness
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Central venous catheter awareness
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Pressure injury awareness
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Actuarial rate of extubation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Reintubation Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of post operative complications
Endpoint domain: Adverse events/effects
Primary endpoint: Overall health related quality of life score (HRQOL)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Rate of Change of Adjusted Lung Density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Safety of Study Drug
Endpoint domain: Adverse events/effects
Primary endpoint: Efficacy of Treatment With Study Drug
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Offspring's body mass index z-score trajectories
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Child cardiometabolic risk score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: erectile dysfunction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Change in CPCHILD score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in Clinical Gait Analysis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in 6-minute walking test
Endpoint domain: Physiological/clinical
Endpoint subdomain: Physical functioning
Primary endpoint: Percent of ventricular function recovery (LVEF) improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in falls rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in plasma glucagon
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Glucose turn-over
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: First Bishop Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Second Bishop Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: The Latent Phase of Labor
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Incidence of Intra Procedural Serious Cardiac Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in inter-recti distance (IRD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Presence of neurological or psychiatric disorders
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in total aortic regurgitation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Ability of the pLAIV vaccine to induce priming
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Frequency of other adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Time under cardiopulmonary bypass
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from Baseline Echocardiogram at 3 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from Baseline Cardiopulmonary Exercise Test at 3 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from Baseline Arterial Stiffness at 3 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from Baseline Intima-Media Thickness at 3 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from rest Arterial Stiffness and post effort
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of Patients With Atrial Thrombus and a Zero ATE Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: change in Transepithelial electrical resistance (TEER)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: change in mucosal permeability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants With Sputum Culture Conversion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Frequency of individual genetic abnormality
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Maximum Tolerated Dose/Maximum Administered Dose (MTD/MAD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinically significant changes in laboratory safety tests
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of postoperative anastomotic leakage
Endpoint domain: Adverse events/effects
Primary endpoint: Distant metastasis rates of rectal cancer
Endpoint domain: Mortality/survival
Primary endpoint: Local recurrence rates of rectal cancer
Endpoint domain: Mortality/survival
Primary endpoint: Five-year survival rates of rectal cancer
Endpoint domain: Mortality/survival
Primary endpoint: calcium balance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Plasmatic levels of cytokines (IL-1B, IL-6, TNF-alfa)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: AUC of carvedilol isomers
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cmax of carvedilol isomers
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Serum 25D concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Incidence Rate of Second Primary Lung Tumor
Endpoint domain: Mortality/survival
Primary endpoint: Changing severity of heart burn
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Changing frequency of symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Percent Change of Circulating Anti-GRP78 IgG Levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Bone Mineral Density Change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Safety tests results
Endpoint domain: Adverse events/effects
Primary endpoint: Change of AF burden
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change of left atrium volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of participants hospitalized for cardiovascular or all causes
Endpoint domain: Mortality/survival
Primary endpoint: Chest wall motion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of patients with a decrease of 5% in weight
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in Posttraumatic Symptoms
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in Distress (Anxiety and Depression)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Disease activity in SLE patients
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: all-causes mortality
Endpoint domain: Mortality/survival
Primary endpoint: non fatal myocardial infarction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: non fatal stroke
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Salivary Flow
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Gait Speed change
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improvement in clinical condition assessed using UPDRS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Return To Work Self Efficacy
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Incidence of breast cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Patients' Perceptions of Pain
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Energy Intake following food commercials
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Energy Intake following toy commercials
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in blood free amino acids
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change from ultrasonographic entesitis score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of mature oocytes post Decapeptyl administration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Toxicity during therapy
Endpoint domain: Adverse events/effects
Primary endpoint: Number of patients with incisional hernia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: The raise of Impedance Threshold of the Atrial and Ventricle
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: RA sensing amplitude (daily mean): < 1.5 mV or RV sensing amplitude (daily min.): < 2.0 mV
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: The proportion of patients with CIED who need MRI examination
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Surgical quality based on pathological examination
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Disease Control Rate (DCR) at 6 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Cognitive Control
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Opioid consumption after surgery
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Bone mass-lumbar spine and hip
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of Women Who Develop One or More New NVP Resistance Mutations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Area Under the Curve Pharmacokinetic Outcome for LPV/r
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Concentration Pharmacokinetic Outcome for LPV/r
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants Who Developed Clinically Significant Factor VIII (FVIII) Inhibitors
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Suppression of laryngo tracheal reflexes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Receipt of the First HPV Vaccination
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in serum alanine aminotransferase levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Central-line associated bloodstream infections rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: TITIM test positivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: change in total distance walked during a 6MWT
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: change of cognitive function
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Position of the implant
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Median time to testosterone recovery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change From Baseline in Target Area Hair Count (TAHC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Prevalence of auto-antibodies against BPAG1/2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Post Operative Pain Control
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Presence of post operative infection
Endpoint domain: Adverse events/effects
Primary endpoint: Criteria validity of MESA questionnaire
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: clinical test of sensory interaction on balance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Medical Problems Detected
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Near visual acuity assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence proportion of serious adverse events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence rate of serious adverse events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: No evidence of disease activity (NEDA) - proportion of participants with no relapses
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: No evidence of disease activity (NEDA) - proportion of participants with no disability progression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Indication of acute renal allograft rejection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Time to symptoms resolution
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Average Number of Micturition Episodes Per Day
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Average Number of Urgency Episodes Per Day
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Global incidence of endometrial changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: number of refluxes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Seropositivity for Japanese Encephalitis Neutralizing Antibodies
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in management resulting from PET
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Deficit development in patients with compensated cirrhosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants Per Category of Global Tolerability Assessed by the Investigator
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1
Endpoint domain: Adverse events/effects
Primary endpoint: Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: 1 month tobacco smoking prevalence
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Seropositivity Rate (SPR) to Hepatitis A
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Pain After Surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Serum IgG levels for SARS CoV 2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Concussion Severity Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Duration of concussion symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to start of the return to play protocol
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Accuracy via Simon Task (% correct)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: UPDRS 3 motor score (0-108)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Dementia Rating Scale Score (0-144 points)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cognitive outcomes
Primary endpoint: Number of patients with congenital heart disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Long term symptoms of mild traumatic brain injury
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: 123-MIBG Washout rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: 123-MIBG heart-to-mediastinum ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Muscle Sympathetic nerve activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: number of ESBL-producing strains
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: mobility score
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: socialization score
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: percentage of microparticule
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Need for general anaesthesia
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: St. George's Respiratory Questionnaire (SGRQ) - Total score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Patient office visits with physician
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Physician phone call to patient
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Complication rate occurrence
Endpoint domain: Adverse events/effects
Primary endpoint: sodium level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes