| Primary | Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System | | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Percentage of Patients, if Any, With Tablets Dispensed But Not Requested | | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™(sufentanil sublingual tablet system) 15 mcg Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for up to 72 hours |
| | |
| Primary | Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout | | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™(sufentanil sublingual tablet system) 15 mcg Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours |
| | |
| Primary | Percentage of Patients With Misplaced Tablet(s) | | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours |
| | | Title | Denominators | Categories |
|---|
|
| Primary | Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth) | | | Posted | | Number | | tablets | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | | Title | Denominators | Categories |
|---|
|
| Primary | Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure) | | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing | | | Posted | | Number | | Notifications | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System | | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™(sufentanil sublingual tablet system) 15 mcg Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for up to 72 hours |
| | |
| Primary | Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap | | | Posted | | Number | | percentage of participants | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent" | | This assessment completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours | | This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor" | | This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good" | | This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent" | | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Rate the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent" | | Overall number of HCPs who completed the assessment. In rare cases, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Fair" at 24 Hours | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for at least 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| | |
| Primary | Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent" | | Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error. | Posted | | Number | | percentage of HCPs | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| |
| Primary | Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period | | | Posted | | Number | | percentage of patients | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia After the 24-hour Study Period and Prior to or During the 48 Hour Study Period | | | Posted | | Number | | percentage of patients | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| | |
| Primary | Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period | | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
| | |
| Primary | Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24) | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 24 hour period. The time-weighted SPID24 is the time-weighted summed PID over the 24-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from - 72 to 204. | | Posted | | Mean | Standard Error | units on a scale | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points and throughout the 48 hour period. The time-weighted SPID48 is the time-weighted summed PID over the 48-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from -144 to 408. | | Posted | | Mean | Standard Error | units on a scale | | Up to 48 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 72 hour period. The time-weighted SPID72 is the time-weighted summed PID over the 72-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. The scores ranged from -239 to 624. | | Posted | | Mean | Standard Error | units on a scale | | Up to 72 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
| |
| Primary | Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24) | Total pain relief over the 24-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 96.00. | | Posted | | Mean | Standard Error | units on a scale | | Up to 24 hours | | | | ID | Title | Description |
|---|
| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48) | Total pain relief over the 48-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 192.00. | | Posted | | Mean | Standard Error | units on a scale | | Up to 48 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72) | Total pain relief over the 72-hour study period. A higher TOTPAR means a greater relief in pain. Range of scores was from 0.00 to 288.00. | | Posted | | Mean | Standard Error | units on a scale | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Pain Intensity (PI) at Each Evaluation Time Point | At protocol-specified time points, the patient is asked to self-record his/her current level of pain on an 11-point numerical rating scale where 0 equals no pain and 10 equals the worst possible pain. | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Mean | Standard Error | units on a scale | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Pain Intensity Difference (PID) at Each Evaluation Time Point | The PID at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. The higher the PID score, the lower the pain intensity. The scores ranged from - 239 to 624. | | Posted | | Mean | Standard Error | units on a scale | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Pain Relief (PR) at Each Evaluation Time Point | At protocol-specified time points, the patient is asked to self-record his/her current level of pain relief on 5-point numerical rating scale where 0 equaled no pain relief and 4 equaled complete pain relief. The baseline score references the baseline pain intensity score and the following timepoints reference pain relief scores. | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | Posted | | Mean | Standard Error | units on a scale | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Patient Usability Questionnaire (PUQ) | Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso. | | Posted | | Number | | percentage of patients | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Nurse Usability Questionnaire (NUQ) | Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients | | Posted | | Number | | percentage of HCPs | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Number of Study Drug Doses Used | | | Posted | | Mean | Standard Deviation | doses | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Average Hourly Use of Study Drug | Average number of study drug doses used per hour, adjusting by treatment exposure time and study period | | Posted | | Mean | Standard Deviation | average number of study doses per hour | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Average Inter-dosing Interval (in Minutes) | | | Posted | | Mean | Standard Deviation | average interval (minutes) between doses | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours. |
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| Primary | Total Amount of Supplemental Morphine (mg) Utilized | Supplemental opioid medication (2 mg IV morphine) was allowed in the first 30 minutes after the first on-demand dose of study drug had been administered, if necessary, to keep a patient comfortable. Otherwise, supplemental opioid medication (2 mg IV morphine, no more frequently than hourly) was allowed for pain due to ambulation or with the initiation of passive range of motion therapy throughout the remainder of the study. | Amount of supplemental morphine (mg) utilized by patients | Posted | | Mean | Standard Deviation | amount of morphine (mg) used | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | Zalviso™ 15 mcg | Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours. |
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