Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.

VASPI is a worldwide validated measure of pain intensity. A Visual Analog Score (VAS) for pain is determined by using a horizontal line, 100-millimeter (mm) in length, anchored by word descriptors at each end; no pain (0 mm) on the left end and worst imaginable pain (100 mm) on the right end. The participant was asked to mark on the line the point that they feel represents their current state of pain. A VAS for least pain (over last two weeks), usual pain (over last two weeks), and pain today was determined and averaged to derive the total VAS score ranging from 0 (no pain) to 100 (worst pain imaginable). A last observation carried forward (LOCF) dataset was used to account for missing data where First Visit data could be carried forward.

Time frame: Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)

Population: Intent-to-Treat (ITT) (LOCF) population included all participants who had at least one dose of an IT therapy. Total number of participants for the outcome measures (335) does not match the total number enrolled (219) due to participants switching between treatment arms as allowed per protocol.

Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), any therapeutic interventions including all drug therapies, vital signs, and creatine kinase (CK) if laboratory tests were taken by the physician as part of routine clinical practice. AEs were graded on a 3-point scale; 1) mild - discomfort noticed, but no disruption of normal daily activity, 2) moderate - discomfort sufficient to reduce or affect normal daily activity, 3) severe - incapacitating, with inability to work or to perform normal daily activity. A TEAE was defined as an adverse event (AE) with a start date on or after the date of the First Visit. Where a start date was missing, the AE was considered to be treatment-emergent.

Time frame: From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.

Population: Safety population included all participants who had at least one dose of an IT therapy.

The Brief Pain Inventory-Short Form (BPI-SF) survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was no pain and 10 was pain as bad as you can imagine for each item listed. The pain interference survey scored each item on a scale, where 0 was does not interfere to 10 was completely interferes. The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.

Time frame: Baseline (Visit 1) to Month 12 (Visit 5)

Population: ITT LOCF population

The BPI-SF survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was no pain and 10 was pain as bad as you can imagine for each item listed. The pain interference survey scored each item on a scale, where 0 was does not interfere to 10 was completely interferes. The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores.

Time frame: Baseline (Visit 1) to Termination Visit (12 Months after last participant was enrolled)

Population: ITT LOCF population

The EQ-5D is a standardized instrument used to measure quality of life. It classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each domain has three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state was defined by combining one level from each of the five dimensions. The response to the question of how good or bad the participant's health was today was given on a visual analogue scale of 0 to 100 millimeters (mm), where 0 meant the participant was in the worst imaginable health state today and 100 meant the participant was in the best imaginable health state today. The results for the Health Score were that of the calculated overall score of the five dimensions, where -0.594 is worst health and 1.00 is perfect health. Change is defined as change in actual from the First Visit.

Time frame: Month 12 Visit, End of Study (Termination Visit)

Population: ITT population. Missing items/values used in calculating the partially complete Health Score were imputed using last observation carried forward (LOCF).

Data for this outcome measure was collected as part of the participant's study visit, however was not analyzed as an efficacy endpoint for reporting.

Time frame: 12 months after the last patient was enrolled

Population: Data for this outcome measure was collected as part of the participant's study visit, however was not analyzed as an efficacy endpoint for reporting.