30 closest matches · ranked by relevance
Osteosarcoma · Nephrotoxicity · Ototoxicity
Primary: Change in Urinary Biomarkers of Acute Kidney Injury (AKI) Between Pre-Treatment (Baseline), After CISplatin (C) Treatments, and After HDTMX Treatments — 1.7; 1.7; 2.1…
Hearing Loss
Primary: Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and…
Cisplatin Ototoxicity · Hearing Loss
Primary: Number of Participants With an Ototoxic Hearing Shift — 15; 8 Participants — p=.27
Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Locally Advanced Head and Neck Squamous Cell Carcinoma
Primary: Number of Participants Who Successfully Completed Planned Treatment — 15 Participants
Acute Otitis Media · AOMT
Primary: Number of Subjects With Adverse Events — 19; 14; 4 Participants
Temporary Auditory Threshold Shift
Primary: Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population — 3.23; 1.32; 3.81; 4.07 dbHL — p=<0.05
Tinnitus, Subjective
Primary: Audiometry - Pure Tone Average Done Over 1000, 2000 and 4000 Hertz (HZ) — -0.3; 0.71; -0.8; 0.3 decibels
Otitis Externa
Primary: Otoscopic Examination: Tympanic Membrane — 6; 8; 8 Participants
Noise-Induced Hearing Loss
Primary: Average Threshold Shift at 4 kHz in Both Ears — 3.94; 3.4; 2.77; 2.03 decibels — p=0.58
Subjective Tinnitus
Primary: Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 — 20; 27 Participants — p==0.385
Ototoxicity · Unspecified Adult Solid Tumor
Primary: Ototoxicity Measurement — 7; 7 participants — p=0.89
Brain Tumor · Central Nervous System Tumor · Childhood Germ Cell Tumor
Primary: Incidence of Hearing Loss — 14; 31 Patients
Age-Related Hearing Loss
Primary: Change in Hearing Loss After 4 Weeks of Treatment — -1.114; -1.914 decibels (dB)
Malaria · Falciparum
Primary: Percentage of Participants With Auditory Abnormalities at Day 7 Assessed by Auditory Brainstem Response (ABR) Wave III Latency Changes on Day 7(a Type of Hearing Test)…
Acute Otitis Media · AOMT
Primary: Number of Ears With Otorrhea (Drainage From the Middle Ear) — 8 affected ears
Dizziness
Primary: Change in Static Subjective Visual Vertical (SVV) — 0.69; 0.58; 0.69; 0.89 degrees — p=0.97
Meniere's Disease
Primary: The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12). — 2.191; 2.415 Definitive Vertigo Day — p=0.623
Acute Otitis Externa · Swimmer's Ear
Primary: Number of Subjects Considered a Clinical Cure at Day 8 — 91; 63 Participants
Neonatal Hearing Loss
Primary: Otoacoustic Suppression Measure — 1.95; 1.33; 2.48; 0.36 dB - Unitless Difference in dB SPL
Otitis Media
Primary: Number of Subjects With Post-surgical Otorrhea — 383; 118 Participants
Otomycosis
Primary: Therapeutical Cure (Clinical and Mycological Cure) — 48; 10 Participants
Otomycosis
Primary: Therapeutic Cure (Clinical and Mycological Cure) — 59; 8 Participants
Meniere Disease
Primary: 28-Day Average DVD at Week 12 (Month 3) — 2.869; 3.577 DVD — p=0.312
Acute Otitis Externa
Primary: Therapeutic Cure (Clinical + Microbiological Cure) — 63; 49; 20 Participants
Acute Otitis Externa
Primary: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit — 71.7; 33.3 percentage of participants
Acute Otitis Externa
Primary: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit — 68.7; 40.0 Percentage of participants
Sensorineural Hearing Loss
Primary: Safety: Treatment-Emergent Adverse Events (TEAE) — 13; 5 Participants
Siderosis · Neurological Disorder · Rare Diseases
Primary: Hearing Evaluation - Pure Tone Audiometry — 57.3 decibel hearing level
Hearing Loss
Primary: Proportion of Participants With SENS-401 Detected in Perilymph — 15; 0 Participants
Tinnitus
Primary: Efficacy: Change in Patient-reported Tinnitus Loudness Questionnaire (TLQ) Improvement From Baseline to Follow up Visit 3 (FUV3) — 0.80; 0.63 units on a scale — p=0.32