Exploratory Endpoints Sample Clauses

Exploratory Endpoints. ● The pharmacokinetics (PK) of LB100 and its metabolite endothall. ● The relative abundance of immune cell populations before, during and after treatment. The signaling states that evolve in immune cells during treatment and that differentiate responders from non-responders.

Exploratory Endpoints. Treatment related mortality rate 100 days post allogeneic stem cell transplant (TRM-Allogeneic SCT 100 day survival)Overall survival from the time of allogeneic stem cell transplant (OS-Allogeneic SCT): OS-Allogeneic SCT is evaluated in subjects who undergo allogeneic SCT and is defined as the time from allogeneic SCT to the date of death. Subjects who have not died by the analysis data cutoff date will be censored at their last contact date. • Complete Remission with partial Hematological Recovery (CRh). The incidence of a CRh (see Appendix 1 for definition). All subjects that do not meet the criteria for CRh by the analysis data cutoff date will not be considered to have CRh. • Blast-free hypoplastic or aplastic bone marrow rate: The incidence of blast-free hypoplastic or aplastic bone marrow (see Appendix 1 for definition). All subjects who do not meet the criteria for blast-free hypoplastic or aplastic bone marrow by the analysis date cutoff date will not be considered to have blast-free hypoplastic or aplastic bone marrow. • Partial remission (PR) rate: The incidence of PR (see Appendix 1 for definition). All subjects that do not meet the criteria for PR by the analysis data cutoff date will not be considered to have PR. • The overall complete remission rate (CR and CRi), MRD-negative rate, and DOR among subjects retreated with KTE-X19 (Section 7.11.10) • Level and activity of CAR+ T cells, as well presence CD19+ cells in blood and bone marrow. • Levels of cytokines in serum and CSF.

Exploratory Endpoints. Difference in disease progression according to RECIST 1.1 and iRECIST (Appendix 5) criteria • Compliance rate responding to a phone - based application for the assessment of patient defined symptoms • Improvement in symptoms as recorded by the Patient Personalized Clinical Benefit (PPCB) • Differences in tumor and/or tissue texture on CT scan between the two treatment arms • Differences in gut microbial communities within and between fecal samples using alpha and beta diversity metrics based on 16S rRNA sequencing

Exploratory Endpoints. CST area under the curve (AUC) • Percent of eyes with resolution of fluid (sub-retinal fluid and intraretinal cysts) through week 12 on SD-OCT Additional details on endpoints will be included in the statistical analysis plan.

Exploratory Endpoints. Safety Endpoints • Occurrence, severity, and relationship of local and systemic solicited AEs reported up to 7 days following the booster vaccination. • Occurrence, severity and relationship of unsolicited AEs occurring up to 28 days following the booster vaccination. • Occurrence, severity and relationship of SAEs occurring up to 28 days following the booster vaccination. Immunogenicity Endpoints Pre- and post-booster immunogenicity of HEXASIIL™ vaccine and comparator vaccine viz., SIIPL Pentavac + Poliovac in subjects who have completed the 3-dose primary vaccination series and receive a booster dose at 12-24 months of age as part of the study. • Percentage of toddlers achieving seroprotection for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and seroconversion for poliovirus types 1 & 3 and pertussis, prior to booster dose and 28 days after a booster dose. • Geometric mean concentrations/titres (GMCs/GMTs) for anti- diphtheria, anti-tetanus, anti-pertussis, anti-HBsAg, anti-PRP and anti-polio types 1 & 3 antibodies, prior to booster dose and 28 days after a booster dose.

Exploratory Endpoints. Proportion of patients experiencing a ≥ 75% reduction in the number of migraine headache days from the last 28 days of Baseline to the last 28 days of treatment in each treatment group. • Proportion of patients with fewer than 14 headache days or fewer than 8 migraine headache days per 4 weeks over the 12-week period. • Mean change from Baseline in number of headache free days from the last 28 days of Baseline to the last 28 days of treatment. • PGIC rating (1-7) at Week 12

Exploratory Endpoints. Exploratory endpoints are provided below. The analysis and subsequent results of these assessments may be reported in separate documents and not included in the Statistical Analysis Plan or Clinical Study Report, respectively. • EORTC QLQ-C30/OV-28, EQ5D-5L, and PGIS • PK parameters will not be calculated due to the use of a sparse sampling schedule. Summary statistics of intact ADC, total Ab, DM4 and S-methyl DM4 concentration data by time will be presented • Immunogenicity is defined as the presence of ADA to MIRV. Based on seroconversion status, the impact of ADA on both efficacy and safety will be evaluated • Identification of soluble FRα levels and other biomarkers, such as protein, genetic, and/or gene expression changes, related to solid malignancies and/or MIRV or IC Chemo mechanism of action. Patient samples will only be used for exploratory research related to this trial and the development of MIRV 3.1. Criteria for Selection of Patient Population 3.1.1. Inclusion Criteria 1. Female patients ≥ 18 years of age 2. Patients must have a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer 3. Patients must have platinum-resistant disease: a. Patients who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and ≤ 6 months after the date last dose of platinum b. Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression Note: Patients who are platinum-refractory during front-line treatment are excluded (see exclusion criteria) 4. Patients must have progressed radiographically on or after their most recent line of therapy 5. Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity 6. Patient’s tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay 7. Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the Investigator) 8. Patients must have received at least 1 b...

Exploratory Endpoints. ‌ Additional exploratory analyses will be conducted to evaluate effects of treatment on Impact of Weight on Quality of Life-Kids (IWQOL-Kids) questionnaire scores, changes in various glycemic and lipid markers, and change in BMI Z-score.

Exploratory Endpoints. PHARMACODYNAMIC ENDPOINTS