Trial Outcomes & Findings for A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092) (NCT NCT00694369)
NCT ID: NCT00694369
Last Updated: 2022-02-09
Results Overview
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
588 participants
Primary outcome timeframe
Over the first 6 hours post the initial Day 1 dose of the study medication
Results posted on
2022-02-09
Participant Flow
Study Conducted at 3 investigational sites in the US. Patients were recruited from the sites patient pool and through advertising. A total of 588 patients were randomized. First Patient Entered 27-June-2008; First Patient In (randomized) on 03-July- 2008; Last Patient Last Visit 08-Jan-09
Patients who met entry criteria and were experiencing moderate-to-severe pain after removal of at least 2 third molars (at least 1 being partially or completely impacted and of mandibular origin) were allocated to the study. Wash-out period for exclusionary medication was specified in the protocol. Randomization was stratified by baseline pain.
Participant milestones
| Measure |
Placebo
Placebo orally once daily
|
Etoricoxib 90 mg
Etoricoxib 90 mg orally once daily
|
Etoricoxib 120 mg
Etoricoxib 120 mg orally once daily
|
Ibuprofen 2400 mg
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
|
Acetaminophen 2400 mg/Codeine 240 mg
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
191
|
97
|
192
|
62
|
|
Overall Study
COMPLETED
|
45
|
188
|
95
|
189
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo orally once daily
|
Etoricoxib 90 mg
Etoricoxib 90 mg orally once daily
|
Etoricoxib 120 mg
Etoricoxib 120 mg orally once daily
|
Ibuprofen 2400 mg
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
|
Acetaminophen 2400 mg/Codeine 240 mg
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
2
|
Baseline Characteristics
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
Placebo orally once daily
|
Etoricoxib 90 mg
n=191 Participants
Etoricoxib 90 mg orally once daily
|
Etoricoxib 120 mg
n=97 Participants
Etoricoxib 120 mg orally once daily
|
Ibuprofen 2400 mg
n=192 Participants
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
|
Acetaminophen 2400 mg/Codeine 240 mg
n=62 Participants
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
|
Total
n=588 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
21.0 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
21.8 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
21.8 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
21.6 years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
20.5 years
STANDARD_DEVIATION 2.8 • n=21 Participants
|
21.5 years
STANDARD_DEVIATION 3.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
340 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
248 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
155 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
432 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
532 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=8 Participants
|
|
Baseline Pain Intensity
Moderate
|
21 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
304 Participants
n=8 Participants
|
|
Baseline Pain Intensity
Severe
|
25 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
284 Participants
n=8 Participants
|
|
Body Weight
|
71.21 Kilograms
STANDARD_DEVIATION 16.33 • n=5 Participants
|
72.53 Kilograms
STANDARD_DEVIATION 16.68 • n=7 Participants
|
71.02 Kilograms
STANDARD_DEVIATION 15.96 • n=5 Participants
|
72.24 Kilograms
STANDARD_DEVIATION 16.81 • n=4 Participants
|
69.43 Kilograms
STANDARD_DEVIATION 13.99 • n=21 Participants
|
71.76 Kilograms
STANDARD_DEVIATION 16.29 • n=8 Participants
|
|
Duration of Surgery
|
0.14 Hours
STANDARD_DEVIATION 0.06 • n=5 Participants
|
0.13 Hours
STANDARD_DEVIATION 0.06 • n=7 Participants
|
0.15 Hours
STANDARD_DEVIATION 0.08 • n=5 Participants
|
0.14 Hours
STANDARD_DEVIATION 0.06 • n=4 Participants
|
0.13 Hours
STANDARD_DEVIATION 0.06 • n=21 Participants
|
0.14 Hours
STANDARD_DEVIATION 0.06 • n=8 Participants
|
|
Height
|
171.03 Centimeters
STANDARD_DEVIATION 8.91 • n=5 Participants
|
168.39 Centimeters
STANDARD_DEVIATION 9.95 • n=7 Participants
|
167.92 Centimeters
STANDARD_DEVIATION 10.07 • n=5 Participants
|
168.50 Centimeters
STANDARD_DEVIATION 9.05 • n=4 Participants
|
168.38 Centimeters
STANDARD_DEVIATION 9.86 • n=21 Participants
|
168.56 Centimeters
STANDARD_DEVIATION 9.59 • n=8 Participants
|
|
Mean Impaction Score
|
2.41 Units on a Scale
STANDARD_DEVIATION 0.51 • n=5 Participants
|
2.44 Units on a Scale
STANDARD_DEVIATION 0.50 • n=7 Participants
|
2.40 Units on a Scale
STANDARD_DEVIATION 0.52 • n=5 Participants
|
2.50 Units on a Scale
STANDARD_DEVIATION 0.48 • n=4 Participants
|
2.40 Units on a Scale
STANDARD_DEVIATION 0.51 • n=21 Participants
|
2.45 Units on a Scale
STANDARD_DEVIATION 0.50 • n=8 Participants
|
|
Number of Hours from End of Surgery to Dosing
|
3.06 Hours
STANDARD_DEVIATION 0.79 • n=5 Participants
|
2.94 Hours
STANDARD_DEVIATION 0.77 • n=7 Participants
|
2.84 Hours
STANDARD_DEVIATION 0.75 • n=5 Participants
|
3.01 Hours
STANDARD_DEVIATION 0.84 • n=4 Participants
|
2.97 Hours
STANDARD_DEVIATION 0.78 • n=21 Participants
|
2.96 Hours
STANDARD_DEVIATION 0.79 • n=8 Participants
|
|
Number of Teeth Removed
|
2.04 Teeth
STANDARD_DEVIATION 0.29 • n=5 Participants
|
2.06 Teeth
STANDARD_DEVIATION 0.27 • n=7 Participants
|
2.10 Teeth
STANDARD_DEVIATION 0.39 • n=5 Participants
|
2.02 Teeth
STANDARD_DEVIATION 0.12 • n=4 Participants
|
2.03 Teeth
STANDARD_DEVIATION 0.18 • n=21 Participants
|
2.05 Teeth
STANDARD_DEVIATION 0.26 • n=8 Participants
|
PRIMARY outcome
Timeframe: Over the first 6 hours post the initial Day 1 dose of the study medicationPopulation: Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo orally once daily
|
Etoricoxib 90 mg
n=191 Participants
Etoricoxib 90 mg orally once daily
|
Etoricoxib 120 mg
n=97 Participants
Etoricoxib 120 mg orally once daily
|
Ibuprofen 2400 mg
n=192 Participants
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
|
Acetaminophen 2400 mg/Codeine 240 mg
n=62 Participants
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
|
|---|---|---|---|---|---|
|
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
|
5.08 Units on a Scale
Standard Error 0.86
|
16.10 Units on a Scale
Standard Error 0.42
|
15.73 Units on a Scale
Standard Error 0.59
|
15.67 Units on a Scale
Standard Error 0.42
|
11.83 Units on a Scale
Standard Error 0.74
|
SECONDARY outcome
Timeframe: At 24 hours post the initial Day 1 dose of the study medicationPopulation: Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.
Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain.
Outcome measures
| Measure |
Placebo
n=44 Participants
Placebo orally once daily
|
Etoricoxib 90 mg
n=184 Participants
Etoricoxib 90 mg orally once daily
|
Etoricoxib 120 mg
n=86 Participants
Etoricoxib 120 mg orally once daily
|
Ibuprofen 2400 mg
n=180 Participants
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
|
Acetaminophen 2400 mg/Codeine 240 mg
n=54 Participants
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
|
|---|---|---|---|---|---|
|
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
Very Good
|
5 Participants
|
66 Participants
|
26 Participants
|
73 Participants
|
18 Participants
|
|
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
Poor
|
19 Participants
|
12 Participants
|
7 Participants
|
6 Participants
|
1 Participants
|
|
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
Fair
|
12 Participants
|
12 Participants
|
5 Participants
|
24 Participants
|
13 Participants
|
|
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
Good
|
5 Participants
|
43 Participants
|
20 Participants
|
42 Participants
|
15 Participants
|
|
Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
Excellent
|
3 Participants
|
51 Participants
|
28 Participants
|
35 Participants
|
7 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Etoricoxib 90 mg
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Etoricoxib 120 mg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Ibuprofen 2400 mg
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Acetaminophen 2400 mg/Codeine 240 mg
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=46 participants at risk
Placebo orally once daily
|
Etoricoxib 90 mg
n=191 participants at risk
Etoricoxib 90 mg orally once daily
|
Etoricoxib 120 mg
n=97 participants at risk
Etoricoxib 120 mg orally once daily
|
Ibuprofen 2400 mg
n=192 participants at risk
Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally
|
Acetaminophen 2400 mg/Codeine 240 mg
n=62 participants at risk
Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally
|
|---|---|---|---|---|---|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
4.2%
8/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
3.1%
3/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
4.2%
8/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
2/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Eye disorders
Blepharospasm
|
2.2%
1/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Eye disorders
Dry Eye
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
2/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
3/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
3/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
3/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
3.1%
6/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
4.1%
4/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
5.2%
10/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
37.1%
23/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
2/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
2/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
24.2%
15/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Asthenia
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Chills
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Facial pain
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Fatigue
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
3/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Feeling cold
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Feeling hot
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Influenza like illness
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Malaise
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
General disorders
Thirst
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Influenza
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
2.1%
2/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Oral infection
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Investigations
Heart rate increased
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.2%
1/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Dizziness
|
4.3%
2/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
2.1%
4/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
3/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
16.1%
10/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
2/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
3.1%
3/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Headache
|
13.0%
6/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
5.8%
11/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
5.2%
5/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
4.2%
8/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
14.5%
9/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
2.1%
4/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
2.1%
2/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
3.1%
6/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
8.1%
5/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
2.2%
1/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
2/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
1/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
3.2%
2/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Vascular disorders
Flushing
|
4.3%
2/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.0%
1/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Vascular disorders
Haematoma
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Vascular disorders
Hot flush
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
1.6%
1/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
|
Vascular disorders
Pallor
|
0.00%
0/46 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/191 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/97 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.52%
1/192 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
0.00%
0/62 • Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER