Trial Outcomes & Findings for Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis (NCT NCT02761993)
NCT ID: NCT02761993
Last Updated: 2021-07-22
Results Overview
The primary efficacy endpoint of this study is the change from baseline in the PD at 9 months (Day 270) for those pockets ≥6 mm at baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Baseline; 9 months
Results posted on
2021-07-22
Participant Flow
Participant milestones
| Measure |
Group 1
Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
49
|
50
|
|
Overall Study
COMPLETED
|
50
|
43
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
4
|
Reasons for withdrawal
| Measure |
Group 1
Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
Baseline Characteristics
Safety, Efficacy and Treatment Regimen Study of ST266 in Subjects With Moderate to Severe Periodontitis
Baseline characteristics by cohort
| Measure |
Group 1
n=52 Participants
Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
n=49 Participants
Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
n=50 Participants
Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 12.52 • n=39 Participants
|
51.6 years
STANDARD_DEVIATION 11.91 • n=41 Participants
|
52.5 years
STANDARD_DEVIATION 11.16 • n=35 Participants
|
51.1 years
STANDARD_DEVIATION 11.88 • n=31 Participants
|
|
Age, Customized
≤ 55 years
|
34 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
91 Participants
n=31 Participants
|
|
Age, Customized
55 - ≤ 65 years
|
13 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
41 Participants
n=31 Participants
|
|
Age, Customized
> 65 years
|
5 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
68 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
83 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
35 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
115 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
38 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
70 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
30 Participants
n=31 Participants
|
|
Smoking Status
Smoker
|
13 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
40 Participants
n=31 Participants
|
|
Smoking Status
Non-Smoker
|
39 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
111 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline; 9 monthsPopulation: Intention-to-Treat (ITT) population: All randomized subjects with non-missing data for a given endpoint and time point. If the proportion of subjects (and oral sites) with missing data is ≤5 percent, as we expect it to be, for these analyses we will use the non-missing data and ignore the missingness.
The primary efficacy endpoint of this study is the change from baseline in the PD at 9 months (Day 270) for those pockets ≥6 mm at baseline.
Outcome measures
| Measure |
Group 1
n=1323 Tooth-Sites
Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
n=1338 Tooth-Sites
Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
n=1374 Tooth-Sites
Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
|---|---|---|---|
|
Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline
Pocket Depth (mm) - Baseline
|
6.6 Pocket Depth (mm)
Standard Deviation 0.93
|
6.6 Pocket Depth (mm)
Standard Deviation 1.02
|
6.7 Pocket Depth (mm)
Standard Deviation 1.03
|
|
Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline
Pocket Depth (mm) - Day 270
|
4.5 Pocket Depth (mm)
Standard Deviation 1.45
|
4.6 Pocket Depth (mm)
Standard Deviation 1.53
|
4.5 Pocket Depth (mm)
Standard Deviation 1.49
|
|
Changes in Pocket Depth (PD) for Those Pockets ≥ 6 mm at Baseline
Pocket Depth (mm) - Change from Baseline
|
-2.1 Pocket Depth (mm)
Standard Deviation 1.40
|
-2.0 Pocket Depth (mm)
Standard Deviation 1.39
|
-2.1 Pocket Depth (mm)
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: Baseline, 9 monthsPopulation: Intention-to-Treat (ITT) population: All randomized subjects with non-missing data for a given endpoint and time point. If the proportion of subjects (and oral sites) with missing data is ≤5 percent, as we expect it to be, for these analyses we will use the non-missing data and ignore the missingness.
Change in Clinical Attachment Level (CAL) (the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ) that is a fixed point, using probing depth and the distance from the gingival margin to the CEJ.) from baseline in CAL at 9 months (Day 270) in tooth sites with baseline PD ≥ 6mm.
Outcome measures
| Measure |
Group 1
n=1323 Tooth-Sites
Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
n=1338 Tooth-Sites
Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
n=1374 Tooth-Sites
Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
|---|---|---|---|
|
Changes in Clinical Attachment Level (CAL)
Clinical Attachment Level (mm) - Day 270
|
5.1 Clinical Attachment Level (mm)
Standard Deviation 2.01
|
5.1 Clinical Attachment Level (mm)
Standard Deviation 1.92
|
5.1 Clinical Attachment Level (mm)
Standard Deviation 2.05
|
|
Changes in Clinical Attachment Level (CAL)
Clinical Attachment Level (mm) - Difference from Baseline
|
-1.6 Clinical Attachment Level (mm)
Standard Deviation 1.48
|
-1.7 Clinical Attachment Level (mm)
Standard Deviation 1.79
|
-1.6 Clinical Attachment Level (mm)
Standard Deviation 1.60
|
|
Changes in Clinical Attachment Level (CAL)
Clinical Attachment Level (mm) - Baseline
|
6.7 Clinical Attachment Level (mm)
Standard Deviation 1.69
|
6.8 Clinical Attachment Level (mm)
Standard Deviation 1.62
|
6.7 Clinical Attachment Level (mm)
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsA secondary efficacy endpoint of this study is change from baseline in BOP at 9 months (Day 270) with BOP for each subject calculated as the percentage of tooth sites in the whole mouth with BOP.
Outcome measures
| Measure |
Group 1
n=52 Participants
Group 1 received ST266 treatment daily on Days 1 through 5, 8 through 12, 22, and 30, and then monthly for 7 months (Days 60, 90, 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
n=49 Participants
Group 2 received ST266 treatment 2x/week (with at least 1 day between treatments) for the first 3 months, and then monthly for 5 months (Days 120, 150, 180, 210, and 240).
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
n=50 Participants
Group 3 received commercially available sterile saline (0.9% sodium chloride) according to the same schedule as Group 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
|---|---|---|---|
|
Bleeding on Probing (BOP)
Bleeding on Probing (%) - Baseline
|
67 Percentage of bleeding tooth-sites
Standard Deviation 17.51
|
62.8 Percentage of bleeding tooth-sites
Standard Deviation 15.84
|
67.5 Percentage of bleeding tooth-sites
Standard Deviation 19.15
|
|
Bleeding on Probing (BOP)
Bleeding on Probing (%) - Day 270
|
40.9 Percentage of bleeding tooth-sites
Standard Deviation 20.80
|
38.8 Percentage of bleeding tooth-sites
Standard Deviation 19.96
|
41.7 Percentage of bleeding tooth-sites
Standard Deviation 25.2
|
|
Bleeding on Probing (BOP)
Bleeding on Probing (%) - Change from Baseline
|
-26.2 Percentage of bleeding tooth-sites
Standard Deviation 18.52
|
-24.0 Percentage of bleeding tooth-sites
Standard Deviation 21.23
|
-25.8 Percentage of bleeding tooth-sites
Standard Deviation 19.42
|
Adverse Events
Group 1
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Group 2
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Group 3
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=52 participants at risk
Group 1: 1XST266 dosed as per regimen 1.
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
n=49 participants at risk
Group 2: 1XST266 as per regimen 2.
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
n=50 participants at risk
Group 3: Placebo dosed as per regimen 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Immune system disorders
Anaphylactic shock
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
Other adverse events
| Measure |
Group 1
n=52 participants at risk
Group 1: 1XST266 dosed as per regimen 1.
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 2
n=49 participants at risk
Group 2: 1XST266 as per regimen 2.
ST266: 1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
Group 3
n=50 participants at risk
Group 3: Placebo dosed as per regimen 1.
Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
|
|---|---|---|---|
|
Gastrointestinal disorders
Tongue disorder
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Gingival pain
|
5.8%
3/52 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.1%
2/49 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
6.0%
3/50 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Toothache
|
5.8%
3/52 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.1%
2/49 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Gingival erythema
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
6.1%
3/49 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Nasopharyngitis
|
13.5%
7/52 • Number of events 7 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
8.2%
4/49 • Number of events 4 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Dental fistula
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Mouth injury
|
5.8%
3/52 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.1%
2/49 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Lip injury
|
5.8%
3/52 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Burn oral cavity
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Tongue injury
|
5.8%
3/52 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Blood pressure increased
|
13.5%
7/52 • Number of events 7 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
10.2%
5/49 • Number of events 5 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
6.0%
3/50 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Blood pressure systolic increased
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.1%
2/49 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Blood pressure diastolic decreased
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.1%
2/49 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Product Issues
Device failure
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Vascular disorders
Hypertension
|
5.8%
3/52 • Number of events 3 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Oral disorder
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Gingival oedema
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Lip haematoma
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Oral pain
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Palatal swelling
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Tongue ulceration
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Tooth resorption
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Gastrointestinal disorders
Traumatic occlusion
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Gastroenteritis viral
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Gingivitis
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Influenza
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.1%
2/49 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Eye infection
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Kidney infection
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Lyme disease
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Oral herpes
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Sinusitis
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Tooth infection
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
4.0%
2/50 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Back injury
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Concussion
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Gingival injury
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Laceration
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Procedural complication
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Blood pressure decreased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Blood urine present
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Haemoglobin urine
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Mean cell volume increased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Monocyte count decreased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Protein urine present
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
Urine leukocyte esterase positive
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Immune system disorders
Seasonal allergy
|
3.8%
2/52 • Number of events 2 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Immune system disorders
Anaphylactic shock
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Product Issues
Device damage
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
General disorders
Adverse drug reaction
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
General disorders
Chills
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
General disorders
Pyrexia
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
General disorders
Complication associated with device
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Eye disorders
Eye swelling
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/50 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
2.0%
1/49 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.9%
1/52 • Number of events 1 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/49 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
0.00%
0/50 • Events that occurred after first treatment dose date and prior to the last treatment dose date + 30 days, a total of up to 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place