Trial Outcomes & Findings for Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL (NCT NCT03682302)
NCT ID: NCT03682302
Last Updated: 2021-01-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
98 participants
Primary outcome timeframe
15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)
Results posted on
2021-01-06
Participant Flow
Participants were recruited between 02 April 2019 and 24 September 2019 at 15 sites in the US (both Groups).
Participant milestones
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
6
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
5
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
1
|
|
Overall Study
Study drug was not administered
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
Baseline characteristics by cohort
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=31 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
n=30 Participants
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=5 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=29 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.8 years
STANDARD_DEVIATION 1.33 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 1.33 • n=7 Participants
|
10 years
STANDARD_DEVIATION 1.73 • n=5 Participants
|
8.7 years
STANDARD_DEVIATION 1.77 • n=4 Participants
|
12.1 years
STANDARD_DEVIATION 2.81 • n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
5 participants
n=5 Participants
|
29 participants
n=4 Participants
|
95 participants
n=21 Participants
|
|
American Society of Anesthesiologists classification
ASA 1
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
American Society of Anesthesiologists classification
ASA 2
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
American Society of Anesthesiologists classification
ASA 3
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)Population: The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
Outcome measures
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=16 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
n=15 Participants
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
0.5% Bupivacaine HCl: Bupivacaine HCl 2mg/kg
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=2 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=21 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity
|
14246.1 ng*h/mL
Standard Deviation 9118.83
|
5709.4 ng*h/mL
Standard Deviation 3281.74
|
11569.5 ng*h/mL
Standard Deviation 7306.07
|
26164.0 ng*h/mL
Standard Deviation 28038.35
|
PRIMARY outcome
Timeframe: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)Population: The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
Outcome measures
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=16 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
n=15 Participants
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
0.5% Bupivacaine HCl: Bupivacaine HCl 2mg/kg
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=2 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=21 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
357.3 ng/mL
Standard Deviation 125.31
|
563.6 ng/mL
Standard Deviation 320.93
|
319.5 ng/mL
Standard Deviation 164.76
|
447.1 ng/mL
Standard Deviation 243.41
|
PRIMARY outcome
Timeframe: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)Population: The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
Outcome measures
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=16 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
n=15 Participants
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
0.5% Bupivacaine HCl: Bupivacaine HCl 2mg/kg
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=2 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=21 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
|---|---|---|---|---|
|
The Apparent Terminal Elimination Half-life (t1/2el)
|
26.8 hours
Standard Deviation 21.26
|
8.4 hours
Standard Deviation 6.26
|
13.4 hours
Standard Deviation 4.60
|
24.9 hours
Standard Deviation 20.58
|
PRIMARY outcome
Timeframe: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)Population: The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
Outcome measures
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=16 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
n=15 Participants
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
0.5% Bupivacaine HCl: Bupivacaine HCl 2mg/kg
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=2 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=21 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F)
|
17.5 Liters/hour
Standard Deviation 7.47
|
20.5 Liters/hour
Standard Deviation 8.27
|
14.5 Liters/hour
Standard Deviation 2.70
|
7.4 Liters/hour
Standard Deviation 3.20
|
PRIMARY outcome
Timeframe: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)Population: The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
Outcome measures
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=16 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
n=15 Participants
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
0.5% Bupivacaine HCl: Bupivacaine HCl 2mg/kg
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=2 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=21 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F)
|
546.4 Liters
Standard Deviation 269.42
|
226.8 Liters
Standard Deviation 110.63
|
271.1 Liters
Standard Deviation 43.58
|
216.1 Liters
Standard Deviation 83.77
|
PRIMARY outcome
Timeframe: 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)Population: The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
Outcome measures
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=16 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacine
n=15 Participants
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
0.5% Bupivacaine HCl: Bupivacaine HCl 2mg/kg
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=2 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=21 Participants
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
Exparel: EXPAREL 4mg/kg (maximum 266 mg)
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Tlast
|
9042.5 ng*h/mL
Standard Deviation 3762.82
|
5232.9 ng*h/mL
Standard Deviation 2538.37
|
10249.6 ng*h/mL
Standard Deviation 5956.56
|
16776.4 ng*h/mL
Standard Deviation 7935.80
|
Adverse Events
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacaine
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=31 participants at risk
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacaine
n=30 participants at risk
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=5 participants at risk
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=29 participants at risk
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
3.4%
1/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
3.4%
1/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Infections and infestations
Wound infection fungal
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
3.4%
1/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
Other adverse events
| Measure |
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, EXPAREL
n=31 participants at risk
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 1: 12 to Less Than 17 Years, Undergoing Spine Surgery, Bupivacaine
n=30 participants at risk
Single dose of bupivacaine HCl 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Spine Surgery, EXPAREL
n=5 participants at risk
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
|
Group 2: 6 to Less Than 12 Years, Undergoing Cardiac Surgery, EXPAREL
n=29 participants at risk
Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.8%
8/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
30.0%
9/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
13.8%
4/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
32.3%
10/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
6/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
6.9%
2/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
29.0%
9/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
16.7%
5/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
13.8%
4/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Hypoesthesia oral
|
3.2%
1/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
10.0%
3/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
60.0%
3/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
6.5%
2/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
26.7%
8/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
3.4%
1/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.7%
3/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
10.0%
3/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Eye disorders
Vision blurred
|
12.9%
4/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
10.0%
3/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
60.0%
3/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
3.4%
1/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Eye disorders
Visual impairment
|
6.5%
2/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
6.7%
2/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
6.7%
2/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
6.7%
2/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
6.7%
2/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
6.7%
2/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Vascular disorders
Hypotension
|
6.5%
2/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
23.3%
7/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
40.0%
2/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
12.9%
4/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Delayed recovery from anesthesia
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Cardiac disorders
Tachycardia
|
3.2%
1/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
13.3%
4/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Cardiac disorders
Bradycardia
|
3.2%
1/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
20.0%
1/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.2%
1/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
6.7%
2/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
40.0%
2/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Ear and labyrinth disorders
Hypoacusis
|
6.5%
2/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
3.3%
1/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Renal and urinary disorders
Incontinence
|
6.5%
2/31 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/30 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/5 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/29 • Screening through postsurgical Day 14
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results conducted at Site shall not be published before 1st multicenter publication by Sponsor but can proceed if there is no such publication ≤18 months after study completion/termination at all sites and all data have been received. Before submitting manuscript/materials to an outside person/entity, site shall give Sponsor 60 days to review and comment. Site shall, upon request, further delay publication/presentation for ≤120 days to allow Sponsor to protect its interests in Inventions.
- Publication restrictions are in place
Restriction type: OTHER