Demographics and Baseline Characteristics. Demographic parameters (age, gender, race, weight, body mass index) and baseline PNH disease characteristics, including RBC transfusion history and baseline laboratory measurements, will be summarized to provide an overall description of the study populations. Data will be presented by group and by total patients receiving ALXN2050. For the group switching from eculizumab or danicopan to ALXN2050, a summary of usage prior to screening will also be provided.
Demographics and Baseline Characteristics. Age, sex, race, ethnicity, and baseline assessments will be summarized descriptively by dose level. Subjects with abnormal medical history will be tabulated by treatment arm and body system. Subjects using any prior medications will be tabulated by dose level, Anatomical Therapeutic Chemical levels, and preferred term specified in the World Health Organization Drug Dictionary Enhanced (World Health Organization Drug Dictionary Enhanced, 2011)
Demographics and Baseline Characteristics. Baseline characteristics of the study population (n=348) of HIV-positive MSM are presented in Table 1. The median age was 41 years old, the median age of black participants was younger (36 years old) than white participants (46 years old). The majority of participants identified as homosexual or gay (92.2%), while 6.3% identified as bisexual and 1.4% identified as other. The majority of the participants had more than a high school degree or GED, with 41.7% having at least some college, associate degree, and/or technical school and 44.3% having college, post graduate, or professional degree at baseline. More than two-thirds were employed (68.1%) and less than one-third were in living in poverty at baseline (28.4%). Four black participants reported being homeless, while no white participant reported baseline homelessness. 85.7% of white participants and 69.3% of black participants had health insurance coverage, resulting in about three-fourths of the participants having health insurance coverage at baseline (77.7%). 38.8% of participants reported not being able to pay for medical care within the past 12 months. Many of the participants had mental health conditions, with 43.7% having diagnosed depression and 34.8% having diagnosed anxiety. Both of these conditions were statistically significantly higher in white MSM, than black MSM. Almost one-third of the participants had an STI diagnosis within the past 12 months (31.0%). About three-fourths of the participants had a self-reported undetectable most recent viral load (76.0%). Baseline characteristics related to the HIV care continuum, ART adherence, and health literacy are reported in Table 2. Related to the HIV care continuum, 12.8% of the participants reported having missed a scheduled appointment in the past 12 months, with a significant difference between black and white MSM, with 19.1% of black MSM and 6.9% white MSM reporting this. Additionally, 20.2% of participants had not seen a provider in the past year. A majority (66.3%) of participants reported having a doctor change their HIV medication in the past five years, with reasons being for insurance coverage changes, side effects, copay for medication changed, different medication options available, new medications that could be taken less often, and just because of doctor recommendations. Related to ART adherence, 45.5% of participants reported always taking their HIV medications as supposed to in the past 30 days, 38% reported adhering almost always...
Demographics and Baseline Characteristics. Demographic data, such as age, race, and ethnicity, and baseline characteristics, such as height, weight, and BMI, will be summarized using the Safety Population. Pregnancy test results and drug screen results will be listed but not summarized. Medical history will be listed by participant.
Demographics and Baseline Characteristics. Subject demographics include age, race, sex, and ethnicity. Baseline characteristics include medical history, prior medications, and baseline results of physical exam, EKG, heart rate and blood pressure, BCVA, slit-lamp exam and biomicroscopy, IOP, indirect ophthalmoscopy, SD-OCT, pregnancy test, laboratory tests (hematology, serum chemistry), fundus photography, fluorescein angiography, and OCT-angiography. For assessments performed multiple times before the injection of i.vt. RBM-007, the last pre-injection value will be used as the baseline value.
Demographics and Baseline Characteristics. Subject disposition, demographics and baseline characteristics will be summarized using descriptive statistics.
Demographics and Baseline Characteristics. Summary statistics will be provided for demographic and baseline characteristics by treatment group. Number and percentage will be presented for categorical variables and descriptive statistics including mean, standard deviation, minimum and maximum will be presented for continuous variables.
Demographics and Baseline Characteristics. The study sample was predominantly female (94.3%), and the majority of participants (63.9%) fell into either the middle age (50-64 years old) or elderly (65+ years old) age categories (Table 1). At the beginning of the study, participants on average reported moderate self-efficacy skills, with a mean score of 6.8 on a scale of 10, and neutral (mean = 4.4) perceived total social support. There was a high prevalence of depression at baseline, with half (50.2%) of all participants having symptoms of depressive illness. There was no statistically significant difference in baseline characteristics between Intervention and Wait-listed Control subjects. Attendance of the CDSM intervention was varied, and only 52.3% reported attending at least four of the six CDSM meetings during the study period. Although the intervention was implemented in Hope Clubs, the only outcomes that showed evidence of correlation by Hope Club were self-efficacy (ICC = 0.01) and depression (ICC = 0.06) (Table 2). Self-efficacy Score 0.01 Yes Social Support Score -0.01 No Family Support -0.02 No Friends Support -0.01 No Special Person Support -0.04 No Depression Score 0.06 Yes
