TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Detection of cognitive deficit
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Fear among dentists
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Total ADHD Symptom Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical Global Impression - Improvement
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Response rate defined as complete + partial response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean detectable difference in microvessel density (MVD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Cytomegalovirus Infection or Disease
Endpoint domain: Adverse events/effects
Primary endpoint: Change in schistosome-specific immune responses
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in systemic immune responses
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: endothelial cell function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: expansile capacity of blood vessels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Ventilatory muscle strength
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to reach maximum observed plasma concentration (Tmax) of PF-06700841
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Standard Deviation of Speed (SDS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fluid Responsiveness
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: incidence of combined postoperative complications Grade I and Grade II
Endpoint domain: Adverse events/effects
Primary endpoint: ACR20 Response Rate at 3 Weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ACR20 Response Rate at 3 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Combined rate of cardiovascular events
Endpoint domain: Mortality/survival
Primary endpoint: Changes in inflammatory and coagulation markers
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Response Rate (Complete or Partial)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Subjects Experiencing a Serious Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Change of subfoveal choroidal thickness
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in exhaled end tidal CO2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Safety and tolerability of EDP1503
Endpoint domain: Adverse events/effects
Primary endpoint: Evidence of anti-tumor activity based on ORR
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Immune-related Overall Response Rate (irORR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: First event of Sustained Paroxysmal AF or Persistent AF or stroke or TIA
Endpoint domain: Mortality/survival
Primary endpoint: DOCE at 12 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: renal tubular dysfunction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Safety of intramuscular injections
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of wound size reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change from baseline in OABSS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline in IIEF-5
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Response to intra-arterial acetylcholine
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Proportion of patients whose dose is modified
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number, type, and severity of bleeds
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Systolic Ambulatory Blood Pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Biochemical Pregnancy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Urine albumin:creatinine ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: 24 Hour Ambulatory Blood Pressure Monitoring
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Average Diarrhea Duration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Change in Alcohol Use Disorder Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Post Traumatic Stress Disorder Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Alcohol Craving
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Nature, incidence and severity of treatment-emergent adverse events (TEAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of subjects with predefined local AEs
Endpoint domain: Adverse events/effects
Primary endpoint: Local tolerability in the target knee
Endpoint domain: Adverse events/effects
Primary endpoint: performances in executive tasks
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: performances in social cognition tasks
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Pediatric Mortality
Endpoint domain: Mortality/survival
Primary endpoint: Reduction in Headache Intensity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Self-reported Adherence to Each Regimen
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Proportion of Participants Who Indicate They Would be Unlikely Use Study Product in the Future
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaginal, and Dual Use)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Complete Clinical Response (CCR) of Lesion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of WR 279,396 (AEs and SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: frank improvement of symptoms of MGT
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: percentage of immature forms of neutrophils in peripheral blood
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: 24-hour urine homogentisic acid levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Hydroxyproline Concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Neoangiogenesis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Collagen I and III
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Behcet's disease current activity form (BDCAF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: carotid intima media thickness
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Jaw maximum range of motion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Condylar rotation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Condylar translation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mismatch Negativity (MMN)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percentage of Participants Receiving DOR/ISL With ≥0.5 log10 Change in HIV-1 RNA
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Percentage of Participants With ≥1 AEs Through Week 49
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25
Endpoint domain: Adverse events/effects
Primary endpoint: Salivary tumor marker levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Complete re-epithelization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: dizziness felt by the patient
Endpoint domain: Adverse events/effects
Primary endpoint: nausea felt by the patient
Endpoint domain: Adverse events/effects
Primary endpoint: headache felt by the patient
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Patients With Successful Bowel Cleansing (Overall Colon)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Objective Response Rate Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Plasma concentrations of NBI-98854 and metabolites
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Successful ERCP or EUS
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: HbA1c Level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change of Pain at Rest
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Pain in Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Subjective chewing efficiency
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Transpulmonary driving pressure level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Return-to-work
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Change From Baseline in Participant Glucose When Fasting and Fed
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change From Baseline in Participant Insulin When Fasting and Fed
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Conversion in Direction of Nystagmus or Disappearance of Nystagmus
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percent Change in HDL-C From Baseline
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Tooth Movement Change
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Quality of Life Based on GIQLI Global Score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Behavioral change rates for diet, physical activity, and smoking
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Rate of correct answers to recognition tasks of emotional facial expressions
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Motion Sickness as Measured by the MSAQ
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical sensitivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical specificity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: site of airflow limitation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: extent of asthma and distribution of emphysema
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: percentage of excess weight loss
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Vessel Wall Enhancement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Expression levels of mRNA
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Successful cannulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Completing the abortion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in implant stability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in bone height
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Labio/Bucco-Palatal width
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Discontinuations Due to TEAEs
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Clinically Significant Treatment-Emergent Abnormalities in Laboratory Values
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants With Clinically Significant Treatment-Emergent Abnormalities in Vital Signs, Electrocardiograms (ECGs), Pulmonary Function, Physical Findings, and Other Observations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of no cardiac events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Bifidobacteria content in feces
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: butyric acid content in feces
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: p-cresol content in urine
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change in macular pigment optical density
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Development of multiple organ failure
Endpoint domain: Mortality/survival
Primary endpoint: oestradiol (E2) suppression
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Efficacy of Bremelanotide as Measured by FSFI (Question Q1 and Q2)
Endpoint domain: Life impact
Endpoint subdomain: Sexual functioning
Primary endpoint: Efficacy of Bremelanotide as Measured by FSDS-DAO (Item 13)
Endpoint domain: Life impact
Endpoint subdomain: Sexual functioning
Primary endpoint: Hemodynamics changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sedation degree
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Number of Subjects With at Least One Adverse Event During the Study
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Subjects With at Least One Serious Adverse Event During the Study
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Subjects Who Died During the Study
Endpoint domain: Mortality/survival
Primary endpoint: Depression severity as measured by MADRS
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: miRNA profile and markers of inflammation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in brain activation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Grades 3, 4, and 5 treatment-related adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Mean Area Under the Curve (AUClast) of Plasma ManNAc
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Plasma Concentration (Cmax) of ManNAc
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Half-life (t ½) for ManNAc
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: osseous setting
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Patients intention to assisted suicide
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Time to the Next COPD Exacerbation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Complete Cure (Completely Clear Nail and Negative Mycology)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Tolerance of Test Substance
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)
Endpoint domain: Adverse events/effects
Primary endpoint: Complete Remission Rate (CRm + CRi)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Rate of therapeutic re-intervention
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Cost associated with management of common severe adverse events
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Recurrence of pelvic pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Amount of Employment
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Percent Change of Headache Days
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Incidence and nature of dose-limiting toxicities (DLTs)
Endpoint domain: Adverse events/effects
Primary endpoint: Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Years of Life Lost
Endpoint domain: Mortality/survival
Primary endpoint: Incidence of preterm preeclampsia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Incidence of preeclampsia with severe features
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Number of stroke-related health problems
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Number of interventions
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Time to first request of analgesics
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Yellow Zone episodes
Endpoint domain: Adverse events/effects
Primary endpoint: Device malfunction
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Subjects With Antibody-Mediated Rejection (AMR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Number of participants with dose limiting toxicities (DLTs)
Endpoint domain: Adverse events/effects
Primary endpoint: all-cause re-admission
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Mean difference in renal MRI measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Radiation exposure measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in tremor amplitude
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Preferred Method of Administration
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Corticoid reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: DAS 28
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: postoperative visual analog scale (VAS) score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Identification of markers of resistance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: feasibility and tolerability of thalidomide plus radiotherapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Pulmonary function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change in systemic inflammation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Improvement of urodynamic stress incontinence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Severity of fatty liver
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Area under the curve (AUC) of index finger O2 saturation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change in fistula blood flow
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: 24-week progression-free survival (PFS) rate
Endpoint domain: Mortality/survival
Primary endpoint: Number of Responders and Number of Non-responders
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety and Tolerability as Assessed by the Number of Participants With Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Functional Assessment of Cancer Therapy-Breast
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Marital intimacy inventory
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of Subjects Experiencing Any Adverse Event
Endpoint domain: Adverse events/effects