The purpose of this study is to evaluate incidence and prevalence rates of the study endpoints (pigmentary maculopathy \[PM\]/ pigmentary retinopathy \[PR\]/Any, PM/PR/ pentosan polysulfate sodium \[PPS\], and PM/PR/Non-PPS) in relation to PPS exposure, and in participants with interstitial cystitis (IC) but not exposed to PPS; changes in visual acuity (VA) over time; participant treatment journey leading to PPS treatment, and potential risk factors associated with the occurrence of PM/PR/PPS.
Study Type
OBSERVATIONAL
Enrollment
2
Janssen R&D, LLC
Titusville, New Jersey, United States
Clean Cohort: Incidence Rate of Pigmentary Maculopathy (PM)/ Pigmentary Retinopathy (PR)/Any Cases
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium \[PPS\]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Incidence Rate of PM/PR/PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Incidence Rate of PM/PR/Non-PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Prevalence Rate of PM/PR/Any Cases
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Prevalence Rate of PM/PR/PPS
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Prevalence Rate of PM/PR/Non-PPS
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants not exposed to PPS).
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Overall Cohort: Incidence Rate of PM/PR/Any Cases
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium \[PPS\]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Prevalence Rate of PM/PR/Any Cases
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Incidence Rate of PM/PR/PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium \[PPS\]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Prevalence Rate of PM/PR/PPS
Prevalence rate is defined as number of prevalent cases per number of target cohort assessed (example, number of participants exposed to PPS).
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Number of PM/PR/PPS Cases Among the PM/PR/Any Cases
Number of PM/PR/PPS cases among the PM/PR/any cases will be reported.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Clean Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than \[\<\] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) greater than or equal to (\>=) 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Change in VA in Relation to PM/PR/Any Cases
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohort: Change in VA in Relation to PM/PR/PPS
Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Clean Cohorts: Change in VA in Relation to PM/PR/Non-PPS
Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 22-May-2018 to 31-Mar-2021 will be examined
Overall Cohort: Change in Visual Acuity (VA) in Relation to PPS Dose
Change in VA in relation to PPS dose will be reported. It will be assessed based on the following categories: a) No change (refers to less than \[\<\] 1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) greater than or equal to (\>=) 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Change in VA in Relation to PM/PR/Any Cases
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Change in VA in Relation to PM/PR/PPS
Change in VA in relation to study endpoint (PM/PR/PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Overall Cohort: Change in VA in Relation to PM/PR/Non-PPS
Change in VA in relation to study endpoint (PM/PR/Non-PPS) will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Interstitial Cystitis (IC) Cohort: Incidence Rate of PM/PR/Any Cases Among the Participants with IC and No-Exposure to PPS
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants not exposed to PPS). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases per number of person-years time at risk.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA in Relation to PM/PR/Any Cases
Change in VA in relation to study endpoint (PM/PR/Any) will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA Based on Age
Change in VA based on age among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA Based on Sex
Change in VA based on sex among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
IC Cohort: Change in VA Based on Time Between the First and Last VA Measurement in Matched Cohorts
Change in VA based on time between the first and last VA measurement in matched cohorts among participants exposed to PPS and without exposure to PPS will be reported. It will be assessed based on the following categories: a) No change (refers to \<1 line of worsening or improvement, considered not clinically meaningful); b) 1 to \<3 lines of worsening; c) \>= 3 lines of worsening; d) 1 to \<3 lines of improvement; e) \>= 3 lines of improvement.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Demographic characteristics of Cohorts: Age
Demographic characteristics of cohorts (age) will be reported.
Time frame: Baseline
Demographic characteristics of Cohorts: Sex
Demographic characteristics of cohorts (sex) will be reported.
Time frame: Baseline
Demographic characteristics of Cohorts: Race
Demographic characteristics of cohorts (race including Asian, black or African American, other, White or Caucasian) will be reported.
Time frame: Baseline
Demographic characteristics of Cohorts: Ethnicity
Demographic characteristics of cohorts (ethnicity including Hispanic and non-Hispanic) will be reported.
Time frame: Baseline
Number of Participants with Comorbidities
Number of participants with general comorbidities (diabetes, hypertension, hypercholesterolemia, vaginitis, urinary tract infection \[UTI\], detrusor instability, urge incontinence, and overactive bladder, autoimmune disease, Malignant tumor(s) of head and neck \[plus documentation of radiation therapy\] and Radiation cystitis) and ocular comorbidities (diabetic retinopathy, diabetic macular edema, optic neuropathy, glaucoma, glaucoma-related procedure, cataract \[diagnosis\], cataract \[procedure\]) will be reported.
Time frame: Baseline
Number of Participants who had Provider Characteristics
Number of participants who had provider characteristics (treating provider specialty \[retina specialist, non-retina specialist, general ophthalmologist, optometrist\]; rural or non-rural location of index practice \[rural/non-rural; United States Department of Agriculture Economic research service 2010 classification\]) will be reported.
Time frame: Baseline
Overall Cohort: Distribution of International Classification of Diseases (ICD)-9/10 Codes
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ICD-9/10 codes are compared among the participants who are exposed to PPS will be reported.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined
Participant's Journey to PPS
Participant's journey to PPS is defined as the sequence of medications and other interventions the participant received before and after receiving PPS.
Time frame: Data analysed retrospectively from 01-Jan-2015 to 31-Mar-2021 will be examined