Trial Outcomes & Findings for Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg (NCT NCT02662764)

NCT ID: NCT02662764

Last Updated: 2018-08-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 320 participants
• Primary outcome timeframe: Up to 72 hours
• Results posted on: 2018-08-08

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	320
Overall Study COMPLETED	290
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	6
Overall Study Lack of Efficacy	8
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	5
Overall Study Device failure	4
Overall Study Patient changed treatment	1
Overall Study Patient discharged prior to 24 hrs	5

Baseline Characteristics

Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

Baseline characteristics by cohort

Measure	Zalviso™ 15 mcg n=320 Participants 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
Age, Customized Age, Customized · <65	198 Participants n=5 Participants
Age, Customized Age, Customized · > or equal to 65	122 Participants n=5 Participants
Sex: Female, Male Female	193 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	302 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants
Race (NIH/OMB) White	280 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System	2.2 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients, if Any, With Tablets Dispensed But Not Requested	0 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout	0 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients With Misplaced Tablet(s)	3.8 percentage of patients

PRIMARY outcome

Timeframe: Up to 24 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)	13 tablets

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)	5.6 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing	0 Notifications

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System	2.2 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap	2.8 percentage of participants

PRIMARY outcome

Timeframe: Up to 24 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent"	86.1 percentage of patients

PRIMARY outcome

Timeframe: Up to 48 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=113 Participants 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.
Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent"	88.5 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=14 Participants 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.
Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent"	100 percentage of patients

PRIMARY outcome

Timeframe: Up to 24 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=294 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours	1.4 percentage of patients

PRIMARY outcome

Timeframe: Up to 24 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=294 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours	12.6 percentage of patients

PRIMARY outcome

Timeframe: Up to 24 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=294 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours	40.8 percentage of patients

PRIMARY outcome

Timeframe: Up to 24 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=294 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours	45.2 percentage of patients

PRIMARY outcome

Timeframe: Up to 48 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=113 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"	0.9 percentage of patients

PRIMARY outcome

Timeframe: Up to 48 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=113 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"	10.6 percentage of patients

PRIMARY outcome

Timeframe: Up to 48 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=113 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"	41.6 percentage of patients

PRIMARY outcome

Timeframe: Up to 48 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=113 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"	46.9 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=14 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"	0 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=14 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"	0 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=14 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"	42.9 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Population: 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.

Outcome measures

Measure	Zalviso™ 15 mcg n=14 Participants 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.
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"	57.1 percentage of patients

PRIMARY outcome

Timeframe: Up to 24 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=270 Participants 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.
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"	91.1 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 48 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=102 Participants 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.
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"	95.1 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Overall number of HCPs who completed the assessment. In rare cases, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=12 Participants 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.
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"	100 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 24 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=270 Participants 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.
Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours	0.7 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 24 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=270 Participants 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.
Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Fair" at 24 Hours	8.1 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 24 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=270 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours	38.9 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 24 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=270 Participants 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.
Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours	52.2 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 48 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=102 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor"	1.0 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 48 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=102 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair"	3.9 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 48 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=102 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good"	27.5 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 48 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=102 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent"	67.6 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=12 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor"	0 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=12 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair"	0 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=12 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good"	8.3 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.

Outcome measures

Measure	Zalviso™ 15 mcg n=12 Participants 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.
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent"	91.7 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 24 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period	2.5 percentage of patients

PRIMARY outcome

Timeframe: Up to 48 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=290 Participants 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.
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	2.8 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=93 Participants 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.
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period	0 percentage of patients

PRIMARY outcome

Timeframe: Up to 24 hours

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=313 Participants 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.
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)	63.09 units on a scale Standard Error 2.58

PRIMARY outcome

Timeframe: Up to 48 hours

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=313 Participants 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.
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period	130.69 units on a scale Standard Error 5.56

PRIMARY outcome

Timeframe: Up to 72 hours

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=313 Participants 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.
Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period	204.66 units on a scale Standard Error 8.61

PRIMARY outcome

Timeframe: Up to 24 hours

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=318 Participants 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.
Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24)	54.27 units on a scale Standard Error 1.14

PRIMARY outcome

Timeframe: Up to 48 hours

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=318 Participants 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.
Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48)	111.42 units on a scale Standard Error 2.35

PRIMARY outcome

Timeframe: Up to 72 hours

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=318 Participants 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.
Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72)	171.10 units on a scale Standard Error 3.70

PRIMARY outcome

Timeframe: Up to 72 hours

Population: 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.

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=313 Participants 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.
Pain Intensity (PI) at Each Evaluation Time Point 2 hours	3.37 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 4 hours	3.39 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 6 hours	3.20 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 8 hours	3.18 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 10 hours	3.10 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 12 hours	2.97 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 32 hours	3.15 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 36 hours	3.06 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 40 hours	2.96 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 44 hours	2.93 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 48 hours	2.82 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 52 hours	2.76 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 56 hours	2.77 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 60 hours	2.75 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 64 hours	2.76 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 68 hours	2.77 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point 72 hours	2.76 units on a scale Standard Error 0.12
Pain Intensity (PI) at Each Evaluation Time Point Baseline	5.84 units on a scale Standard Error 0.07
Pain Intensity (PI) at Each Evaluation Time Point 15 minutes	4.77 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 30 minutes	4.46 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 45 minutes	4.05 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 1 hour	3.70 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 16 hours	3.08 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 20 hours	3.20 units on a scale Standard Error 0.14
Pain Intensity (PI) at Each Evaluation Time Point 24 hours	3.16 units on a scale Standard Error 0.13
Pain Intensity (PI) at Each Evaluation Time Point 28 hours	3.16 units on a scale Standard Error 0.13

PRIMARY outcome

Timeframe: Up to 72 hours

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=313 Participants 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.
Pain Intensity Difference (PID) at Each Evaluation Time Point Baseline	5.84 units on a scale Standard Error 0.07
Pain Intensity Difference (PID) at Each Evaluation Time Point 15 minutes	1.07 units on a scale Standard Error 0.10
Pain Intensity Difference (PID) at Each Evaluation Time Point 30 minutes	1.38 units on a scale Standard Error 0.10
Pain Intensity Difference (PID) at Each Evaluation Time Point 45 minutes	1.79 units on a scale Standard Error 0.11
Pain Intensity Difference (PID) at Each Evaluation Time Point 1 hour	2.14 units on a scale Standard Error 0.11
Pain Intensity Difference (PID) at Each Evaluation Time Point 2 hours	2.48 units on a scale Standard Error 0.12
Pain Intensity Difference (PID) at Each Evaluation Time Point 4 hours	2.45 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 24 hours	2.69 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 28 hours	2.68 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 32 hours	2.69 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 36 hours	2.78 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 52 hours	3.08 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 56 hours	3.08 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 60 hours	3.09 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 64 hours	3.08 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 68 hours	3.08 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 72 hours	3.08 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 6 hours	2.64 units on a scale Standard Error 0.12
Pain Intensity Difference (PID) at Each Evaluation Time Point 8 hours	2.67 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 10 hours	2.74 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 12 hours	2.88 units on a scale Standard Error 0.12
Pain Intensity Difference (PID) at Each Evaluation Time Point 16 hours	2.77 units on a scale Standard Error 0.13
Pain Intensity Difference (PID) at Each Evaluation Time Point 20 hours	2.65 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 40 hours	2.88 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 44 hours	2.91 units on a scale Standard Error 0.14
Pain Intensity Difference (PID) at Each Evaluation Time Point 48 hours	3.02 units on a scale Standard Error 0.14

PRIMARY outcome

Timeframe: Up to 72 hours

Population: 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.

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=318 Participants 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.
Pain Relief (PR) at Each Evaluation Time Point (Not Applicable)	NA units on a scale Standard Error NA Pain relief was not collected at baseline since the patient had not yet received study drug
Pain Relief (PR) at Each Evaluation Time Point 15 minutes	1.18 units on a scale Standard Error 0.07
Pain Relief (PR) at Each Evaluation Time Point 30 minutes	1.42 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 45 minutes	1.67 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 1 hour	1.81 units on a scale Standard Error 0.07
Pain Relief (PR) at Each Evaluation Time Point 2 hours	2.08 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 4 hours	2.12 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 6 hours	2.24 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 20 hours	2.30 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 24 hours	2.42 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 28 hours	2.37 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 32 hours	2.34 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 36 hours	2.34 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 40 hours	2.39 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 44 hours	2.41 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 48 hours	2.44 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 52 hours	2.48 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 56 hours	2.48 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 60 hours	2.49 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 64 hours	2.48 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 68 hours	2.49 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 72 hours	2.50 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 8 hours	2.24 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 10 hours	2.32 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 12 hours	2.37 units on a scale Standard Error 0.06
Pain Relief (PR) at Each Evaluation Time Point 16 hours	2.31 units on a scale Standard Error 0.06

PRIMARY outcome

Timeframe: Up to 72 hours

Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.

Outcome measures

Measure	Zalviso™ 15 mcg n=317 Participants 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.
Patient Usability Questionnaire (PUQ) Agreed Zalviso was easy to use	90.5 percentage of patients
Patient Usability Questionnaire (PUQ) Agreed having confidence to dose	92.4 percentage of patients
Patient Usability Questionnaire (PUQ) Agreed Zalviso worked consistently as expected	82.3 percentage of patients
Patient Usability Questionnaire (PUQ) Agreed they knew how to use Zalviso	93.4 percentage of patients
Patient Usability Questionnaire (PUQ) Agreed they knew what to do if a tablet dropped	86.1 percentage of patients
Patient Usability Questionnaire (PUQ) Agreed Zalviso instructions were explained	91.2 percentage of patients
Patient Usability Questionnaire (PUQ) Agreed to request Zalviso after next surgery	80.4 percentage of patients

PRIMARY outcome

Timeframe: Up to 72 hours

Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients

Outcome measures

Measure	Zalviso™ 15 mcg n=40 Participants 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.
Nurse Usability Questionnaire (NUQ) Agreed Zalviso easy to set up	92.5 percentage of HCPs
Nurse Usability Questionnaire (NUQ) Agreed had confidence to set up Zalviso	92.5 percentage of HCPs
Nurse Usability Questionnaire (NUQ) Agreed no need to trouble-shoot during patient use	87.5 percentage of HCPs
Nurse Usability Questionnaire (NUQ) Agreed with appropriate tablet accountability	100 percentage of HCPs
Nurse Usability Questionnaire (NUQ) Agreed Zalviso was not time-consuming to set up	72.5 percentage of HCPs
Nurse Usability Questionnaire (NUQ) Agreed Zalviso instructions were clear	90 percentage of HCPs
Nurse Usability Questionnaire (NUQ) Would recommend using Zalviso	87.5 percentage of HCPs

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Number of Study Drug Doses Used 24-hour treatment period	15.7 doses Standard Deviation 9.9
Number of Study Drug Doses Used 48-hour treatment period	21.9 doses Standard Deviation 14.8
Number of Study Drug Doses Used 72-hour treatment period	22.8 doses Standard Deviation 15.7

PRIMARY outcome

Timeframe: Up to 72 hours

Average number of study drug doses used per hour, adjusting by treatment exposure time and study period

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Average Hourly Use of Study Drug	0.82 average number of study doses per hour Standard Deviation 0.51

PRIMARY outcome

Timeframe: Up to 72 hours

Outcome measures

Measure	Zalviso™ 15 mcg n=316 Participants 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.
Average Inter-dosing Interval (in Minutes) 24-hour study period	121.4 average interval (minutes) between doses Standard Deviation 116.2
Average Inter-dosing Interval (in Minutes) 48-hour study period	123.2 average interval (minutes) between doses Standard Deviation 151.6
Average Inter-dosing Interval (in Minutes) 72-hour study period	120.9 average interval (minutes) between doses Standard Deviation 109.7

PRIMARY outcome

Timeframe: Up to 72 hours

Population: Amount of supplemental morphine (mg) utilized by patients

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.

Outcome measures

Measure	Zalviso™ 15 mcg n=320 Participants 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.
Total Amount of Supplemental Morphine (mg) Utilized	0.1 amount of morphine (mg) used Standard Deviation 0.4

Adverse Events

Zalviso™ 15 mcg

Serious events: 3 serious events

Other events: 190 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zalviso™ 15 mcg n=320 participants at risk 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
Blood and lymphatic system disorders Anaemia	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Cardiac disorders Cardiac Failure Chronic	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
General disorders Pyrexia	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Injury, poisoning and procedural complications Renal Injury	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Nervous system disorders Sedation	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Vascular disorders Hypotension	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Vascular disorders Labile blood pressure	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Renal and urinary disorders Chronic renal failure	0.31% 1/320 • Number of events 1 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken

Other adverse events

Measure	Zalviso™ 15 mcg n=320 participants at risk 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
Cardiac disorders Bradycardia	5.3% 17/320 • Number of events 34 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Cardiac disorders Tachycardia	2.5% 8/320 • Number of events 8 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Gastrointestinal disorders Nausea	26.2% 84/320 • Number of events 88 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Gastrointestinal disorders Vomiting	10.0% 32/320 • Number of events 49 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Gastrointestinal disorders Constipation	2.5% 8/320 • Number of events 8 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Investigations Oxygen saturation decreased	5.9% 19/320 • Number of events 25 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Metabolism and nutrition disorders Hypokalaemia	4.4% 14/320 • Number of events 14 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Musculoskeletal and connective tissue disorders Muscle spasms	7.8% 25/320 • Number of events 25 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Nervous system disorders Dizziness	4.4% 14/320 • Number of events 16 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Nervous system disorders Headache	3.8% 12/320 • Number of events 13 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Skin and subcutaneous tissue disorders Pruritis	3.4% 11/320 • Number of events 11 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Vascular disorders Hypotension	11.2% 36/320 • Number of events 113 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
General disorders Pyrexia	3.1% 10/320 • Number of events 10 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Vascular disorders Hypertension	2.2% 7/320 • Number of events 7 • From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken

Additional Information

Pamela Palmer, MD, PhD

AcelRx Pharmaceuticals, Inc

Phone: 650-216-3504

Email: ppalmer@acelrx.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator must obtain approval from AcelRx in order to discuss or publish trial results
• Publication restrictions are in place

Restriction type: OTHER