Trial Outcomes & Findings for BMS-986012 in Relapsed/Refractory SCLC (NCT NCT02247349)
NCT ID: NCT02247349
Last Updated: 2024-03-05
Results Overview
Number of participants with any grade adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
106 participants
Primary outcome timeframe
From first dose to 100 days post last dose (Up to 64 months)
Results posted on
2024-03-05
Participant Flow
Participant milestones
| Measure |
BMS 70mg
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
29
|
35
|
21
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
29
|
35
|
21
|
8
|
Reasons for withdrawal
| Measure |
BMS 70mg
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
7
|
4
|
26
|
31
|
16
|
6
|
|
Overall Study
Study drug toxicity
|
0
|
1
|
1
|
1
|
2
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event unrelated to study drug
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant request to discontinue study treatment
|
0
|
0
|
1
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Administrative reason by sponsor
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other reasons
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
BMS-986012 in Relapsed/Refractory SCLC
Baseline characteristics by cohort
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.1 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
64.4 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
61.7 Years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
62.1 Years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
61.1 Years
STANDARD_DEVIATION 7.3 • n=8 Participants
|
62.5 Years
STANDARD_DEVIATION 9.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
61 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
99 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
99 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 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
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Up to 64 months)Population: All treated participants
Number of participants with any grade adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
7 Participants
|
6 Participants
|
29 Participants
|
35 Participants
|
21 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Up to 64 months)Population: All treated participants
Number of participants with any grade serious adverse events (SAEs). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * results in death * is life-threatening * requires inpatient hospitalization or causes prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
7 Participants
|
4 Participants
|
21 Participants
|
24 Participants
|
11 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Up to 64 months)Population: All treated participants
Number of participants with any grade adverse events (AEs) leading to discontinuation. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Leading to Discontinuation
|
0 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Up to 64 months)Population: All treated participants
Number of participants who died due to any cause.
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Died
|
3 Participants
|
2 Participants
|
10 Participants
|
16 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Up to 64 months)Population: All treated participants
Number of participants with laboratory abnormalities in specific hepatic tests. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: * ALT or AST \> 5xULN, \> 3xULN, and \> 2xULN * Any of ALT, AST, Total Bilirubin or ALP \> 8xULN * Total bilirubin \> 3xULN ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Hepatic Test
TOTAL BILIRUBIN > 3XULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Hepatic Test
ALT OR AST > 5XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Hepatic Test
ALT OR AST > 3XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hepatic Test
ALT OR AST > 2XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Hepatic Test
ANY OF ALT, AST, TOTAL BILIRUBIN OR ALP > 8XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 maximum observed serum concentration (Cmax).
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=28 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=32 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Maximum Observed Serum Concentration (Cmax)
cycle 1 day 1
|
27.5 ug/mL
Geometric Coefficient of Variation 31
|
53.8 ug/mL
Geometric Coefficient of Variation 28
|
121 ug/mL
Geometric Coefficient of Variation 26
|
276 ug/mL
Geometric Coefficient of Variation 37
|
111 ug/mL
Geometric Coefficient of Variation 33
|
339 ug/mL
Geometric Coefficient of Variation 25
|
|
BMS-986012 Maximum Observed Serum Concentration (Cmax)
cycle 3 day 1
|
33.8 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
46.9 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
221 ug/mL
Geometric Coefficient of Variation 1
|
279 ug/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 time of maximum observed serum concentration (Tmax).
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=28 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=32 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
cycle 1 day 1
|
2.08 hours
Interval 1.0 to 8.0
|
2.02 hours
Interval 1.0 to 6.33
|
2.00 hours
Interval 1.0 to 6.07
|
1.58 hours
Interval 0.95 to 4.4
|
4.00 hours
Interval 1.0 to 5.4
|
1.53 hours
Interval 1.0 to 4.3
|
|
BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
cycle 3 day 1
|
1.93 hours
Interval 1.93 to 1.93
|
4.00 hours
Interval 4.0 to 4.0
|
2.04 hours
Interval 2.02 to 2.07
|
2.30 hours
Interval 2.05 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)).
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=28 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=32 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
cycle 1 day 1
|
3997 h*ug/mL
Geometric Coefficient of Variation 31
|
5584 h*ug/mL
Geometric Coefficient of Variation 55
|
18456 h*ug/mL
Geometric Coefficient of Variation 32
|
36223 h*ug/mL
Geometric Coefficient of Variation 40
|
16527 h*ug/mL
Geometric Coefficient of Variation 31
|
45126 h*ug/mL
Geometric Coefficient of Variation 24
|
|
BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
cycle 3 day 1
|
7062 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
10560 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
42583 h*ug/mL
Geometric Coefficient of Variation 8
|
58649 h*ug/mL
Geometric Coefficient of Variation 28
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 area under the serum concentration-time curve in one dosing interval AUC (TAU).
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=5 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=26 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=28 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=17 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=6 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
cycle 1 day 1
|
4300 h*ug/mL
Geometric Coefficient of Variation 29
|
8356 h*ug/mL
Geometric Coefficient of Variation 28
|
19865 h*ug/mL
Geometric Coefficient of Variation 28
|
40979 h*ug/mL
Geometric Coefficient of Variation 34
|
18161 h*ug/mL
Geometric Coefficient of Variation 30
|
49031 h*ug/mL
Geometric Coefficient of Variation 26
|
|
BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
cycle 3 day 1
|
7062 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
10560 h*ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
42583 h*ug/mL
Geometric Coefficient of Variation 8
|
62634 h*ug/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 observed serum concentration at the end of a dosing interval (Ctau).
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=5 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=26 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=28 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=17 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=6 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
cycle 1 day 1
|
3.44 ug/mL
Geometric Coefficient of Variation 38
|
6.24 ug/mL
Geometric Coefficient of Variation 31
|
17.4 ug/mL
Geometric Coefficient of Variation 32
|
30.2 ug/mL
Geometric Coefficient of Variation 59
|
14.6 ug/mL
Geometric Coefficient of Variation 44
|
39.5 ug/mL
Geometric Coefficient of Variation 40
|
|
BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
cycle 3 day 1
|
7.39 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
13.6 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
42.4 ug/mL
Geometric Coefficient of Variation 13
|
59.2 ug/mL
Geometric Coefficient of Variation 19
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 total body clearance (CLT).
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=5 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=26 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=28 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=17 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=6 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Total Body Clearance (CLT)
cycle 1 day 1
|
16.3 mL/h
Geometric Coefficient of Variation 38
|
19.1 mL/h
Geometric Coefficient of Variation 27
|
20.1 mL/h
Geometric Coefficient of Variation 24
|
24.4 mL/h
Geometric Coefficient of Variation 86
|
22.0 mL/h
Geometric Coefficient of Variation 30
|
20.4 mL/h
Geometric Coefficient of Variation 28
|
|
BMS-986012 Total Body Clearance (CLT)
cycle 3 day 1
|
9.91 mL/h
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
15.2 mL/h
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
9.39 mL/h
Geometric Coefficient of Variation 8
|
16.0 mL/h
Geometric Coefficient of Variation 40
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 7 day 1, cycle 11 day 1. cycle 15 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 trough observed serum concentration (Ctrough).
Outcome measures
| Measure |
BMS 70mg
n=4 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=4 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=22 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=18 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=13 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=5 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Trough Observed Serum Concentration (Ctrough)
cycle 2 day 1
|
4186 ng/mL
Geometric Coefficient of Variation 27
|
7211 ng/mL
Geometric Coefficient of Variation 17
|
18810 ng/mL
Geometric Coefficient of Variation 29
|
36990 ng/mL
Geometric Coefficient of Variation 54
|
14544 ng/mL
Geometric Coefficient of Variation 84
|
36391 ng/mL
Geometric Coefficient of Variation 43
|
|
BMS-986012 Trough Observed Serum Concentration (Ctrough)
cycle 3 day 1
|
6570 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
9100 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
29232 ng/mL
Geometric Coefficient of Variation 36
|
68589 ng/mL
Geometric Coefficient of Variation 57
|
26016 ng/mL
Geometric Coefficient of Variation 37
|
158801 ng/mL
Geometric Coefficient of Variation 85
|
|
BMS-986012 Trough Observed Serum Concentration (Ctrough)
cycle 4 day 1
|
7390 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
13600 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
35122 ng/mL
Geometric Coefficient of Variation 26
|
90207 ng/mL
Geometric Coefficient of Variation 68
|
26102 ng/mL
Geometric Coefficient of Variation 63
|
157000 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
|
BMS-986012 Trough Observed Serum Concentration (Ctrough)
cycle 7 day 1
|
9040 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
13700 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
38315 ng/mL
Geometric Coefficient of Variation 27
|
107444 ng/mL
Geometric Coefficient of Variation 58
|
38405 ng/mL
Geometric Coefficient of Variation 9
|
—
|
|
BMS-986012 Trough Observed Serum Concentration (Ctrough)
cycle 11 day 1
|
9930 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
—
|
32251 ng/mL
Geometric Coefficient of Variation 14
|
102980 ng/mL
Geometric Coefficient of Variation 67
|
34400 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
—
|
|
BMS-986012 Trough Observed Serum Concentration (Ctrough)
cycle 15 day 1
|
8029 ng/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 Average concentration over a dosing interval (\[AUC(TAU)/tau\] (Css-avg).
Outcome measures
| Measure |
BMS 70mg
n=1 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=1 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=2 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=3 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)
|
13.9 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
22.0 ug/mL
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
82.1 ug/mL
Geometric Coefficient of Variation 11
|
119 ug/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 accumulation index. Ratio of an exposure measure at steady state to that after the first dose.
Outcome measures
| Measure |
BMS 70mg
n=1 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=1 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=2 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=2 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Accumulation Index (AI_AUC)
|
1.56 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
1.55 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
1.62 Ratio
Geometric Coefficient of Variation 22
|
1.39 Ratio
Geometric Coefficient of Variation 51
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 Cmax accumulation index (AI\_Cmax). Ratio of an exposure measure at steady state to that after the first dose.
Outcome measures
| Measure |
BMS 70mg
n=1 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=1 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=2 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=2 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Cmax Accumulation Index (AI_Cmax)
|
0.994 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
1.47 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
1.22 Ratio
Geometric Coefficient of Variation 11
|
0.940 Ratio
Geometric Coefficient of Variation 70
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 Ctau accumulation index (AI\_Ctau). Ratio of an exposure measure at steady state to that after the first dose.
Outcome measures
| Measure |
BMS 70mg
n=1 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=1 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=2 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=2 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Ctau Accumulation Index (AI_Ctau)
|
1.81 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
2.31 Ratio
Geometric Coefficient of Variation NA
insufficient numbers of participants
|
1.76 Ratio
Geometric Coefficient of Variation 0
|
1.08 Ratio
Geometric Coefficient of Variation 82
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)Population: All participants who receive at least 1 dose of BMS-986012 (and Nivolumab in the combination therapy) and have available serum concentration data for the corresponding analyte
BMS-986012 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure.
Outcome measures
| Measure |
BMS 70mg
n=1 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=1 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=2 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=1 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
BMS-986012 Effective Elimination (T-HALFeff)
|
342 Hours
Standard Deviation NA
insufficient numbers of participants
|
319 Hours
Standard Deviation NA
insufficient numbers of participants
|
384 Hours
Standard Deviation 154.2
|
583 Hours
Standard Deviation NA
insufficient numbers of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)Population: All treated participants
BOR defined as the best response designation over the study as a whole. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Best Overall Response (BOR)
Complete Response
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Overall Response (BOR)
Progressive Disease
|
4 Participants
|
2 Participants
|
18 Participants
|
21 Participants
|
9 Participants
|
3 Participants
|
|
Best Overall Response (BOR)
Not evaluable
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Best Overall Response (BOR)
Partial Response
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
|
Best Overall Response (BOR)
Stable Disease
|
0 Participants
|
2 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose date to the date of first documented disease progression (Up to 97 months)Population: All treated participants
ORR is defined as the percent of participants whose BOR is either CR or PR. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
14.3 Percent of participants
Interval 0.4 to 57.9
|
0 Percent of participants
Interval 0.0 to 45.9
|
3.4 Percent of participants
Interval 0.1 to 17.8
|
2.9 Percent of participants
Interval 0.1 to 14.9
|
42.9 Percent of participants
Interval 21.8 to 66.0
|
25.0 Percent of participants
Interval 3.2 to 65.1
|
SECONDARY outcome
Timeframe: From the date of first dose to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 97 months)Population: Median DoR is pre-specified to only be evaluated provided there are enough responders (CR or PR) to warrant inclusion (Only Cohorts with at least 5 events are analyzed)
DoR is defined as the time from first response (CR or PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who remain alive and have not progressed will be censored on the date of their last tumor assessment. Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR )= At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm Median DOR will only be evaluated provided there are enough responding participants to warrant inclusion.
Outcome measures
| Measure |
BMS 70mg
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=9 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
—
|
—
|
—
|
—
|
120.57 Weeks
Interval 12.14 to
Upper Limit not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of first documented disease progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose (Up to 97 months)Population: All treated participants
PFS is defined as the time from the date of first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.50 Weeks
Interval 2.43 to 53.0
|
5.86 Weeks
Interval 5.29 to 30.29
|
5.79 Weeks
Interval 5.57 to 8.0
|
5.36 Weeks
Interval 5.0 to 5.71
|
17.71 Weeks
Interval 6.14 to 120.29
|
5.71 Weeks
Interval 2.71 to 25.0
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48, 60, 72Population: All treated participants
PFSR is defined as the percent of participants who remain progression free and surviving at "t" weeks (t= 12, 24, 36, 48, 60, 72). Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions and the sum must demonstrate an absolute increase of at least 5 mm
Outcome measures
| Measure |
BMS 70mg
n=7 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=6 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=29 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=35 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=21 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=8 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Progression Free Survival Rate (PFSR)
Week 36
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
45.0 Percent of participants
Interval 23.1 to 64.7
|
NA Percent of participants
Insufficient number of participants with events
|
|
Progression Free Survival Rate (PFSR)
Week 72
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
35.0 Percent of participants
Interval 15.7 to 55.2
|
NA Percent of participants
Insufficient number of participants with events
|
|
Progression Free Survival Rate (PFSR)
Week 12
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
21.4 Percent of participants
Interval 8.7 to 37.8
|
20.6 Percent of participants
Interval 9.1 to 35.3
|
55.0 Percent of participants
Interval 31.3 to 73.5
|
NA Percent of participants
Insufficient number of participants with events
|
|
Progression Free Survival Rate (PFSR)
Week 24
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
45.0 Percent of participants
Interval 23.1 to 64.7
|
NA Percent of participants
Insufficient number of participants with events
|
|
Progression Free Survival Rate (PFSR)
Week 48
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
35.0 Percent of participants
Interval 15.7 to 55.2
|
NA Percent of participants
Insufficient number of participants with events
|
|
Progression Free Survival Rate (PFSR)
Week 60
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
NA Percent of participants
Insufficient number of participants with events
|
35.0 Percent of participants
Interval 15.7 to 55.2
|
NA Percent of participants
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)Population: All treated participants who had at least 1 post-treatment immunogenicity assessment
Number of participants with anti-BMS-986012 antibodies (ADA) with status as baseline ADA positive, ADA positive and ADA negative. Baseline ADA positive participant is a participant with baseline ADA positive sample (Day 1 predose). ADA-positive participant is a participant with at least one ADA positive sample relative to baseline at any time after initiation of treatment during the defined observation time period. ADA negative participant is a participant with no ADA positive sample after the initiation of treatment.
Outcome measures
| Measure |
BMS 70mg
n=5 Participants
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg
n=5 Participants
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg
n=27 Participants
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg
n=25 Participants
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg
n=14 Participants
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg
n=7 Participants
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-BMS-986012 Antibodies (ADA)
Baseline ADA positive
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-BMS-986012 Antibodies (ADA)
ADA positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-BMS-986012 Antibodies (ADA)
ADA negative
|
5 Participants
|
5 Participants
|
27 Participants
|
25 Participants
|
14 Participants
|
7 Participants
|
Adverse Events
BMS 70mg SCLC Refractory
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
BMS 70mg SCLC Sensitive
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
BMS 160mg SCLC Refractory
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
BMS 160mg SCLC Sensitive
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
BMS 400mg SCLC Refractory
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
BMS 400mg SCLC Sensitive
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
BMS 400mg SCLC Refractory Expansion
Serious events: 8 serious events
Other events: 12 other events
Deaths: 9 deaths
BMS 400mg SCLC Sensitive Expansion
Serious events: 6 serious events
Other events: 10 other events
Deaths: 9 deaths
BMS 1000mg SCLC Refractory
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
BMS 1000mg SCLC Sensitive
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
BMS 1000mg SCLC Refractory Expansion
Serious events: 8 serious events
Other events: 12 other events
Deaths: 11 deaths
BMS 1000mg SCLC Sensitive Expansion
Serious events: 11 serious events
Other events: 14 other events
Deaths: 12 deaths
BMS 400mg + Nivo 360mg SCLC Refractory
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
BMS 400mg + Nivo 360mg SCLC Sensitive
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
BMS 400mg + Nivo 360mg SCLC Refractory Expansion
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
BMS 400mg + Nivo 360mg SCLC Sensitive Expansion
Serious events: 4 serious events
Other events: 9 other events
Deaths: 4 deaths
BMS 1000mg + Nivo 360mg SCLC Refractory
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
BMS 1000mg + Nivo 360mg SCLC Sensitive
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
BMS 70mg SCLC Refractory
n=3 participants at risk
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 70mg SCLC Sensitive
n=4 participants at risk
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg SCLC Refractory
n=2 participants at risk
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg SCLC Sensitive
n=4 participants at risk
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Refractory
n=3 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Sensitive
n=4 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Refractory Expansion
n=12 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Sensitive Expansion
n=10 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Refractory
n=3 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Sensitive
n=6 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Refractory Expansion
n=12 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Sensitive Expansion
n=14 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Refractory
n=2 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Sensitive
n=6 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Refractory Expansion
n=4 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Sensitive Expansion
n=9 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg SCLC Refractory
n=3 participants at risk
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg SCLC Sensitive
n=5 participants at risk
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Fatigue
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
75.0%
3/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
41.7%
5/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
30.0%
3/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
3/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
6/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
42.9%
6/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
3/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial artery hypertrophy
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
Other adverse events
| Measure |
BMS 70mg SCLC Refractory
n=3 participants at risk
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 70mg SCLC Sensitive
n=4 participants at risk
70 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg SCLC Refractory
n=2 participants at risk
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 160mg SCLC Sensitive
n=4 participants at risk
160 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Refractory
n=3 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Sensitive
n=4 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Refractory Expansion
n=12 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg SCLC Sensitive Expansion
n=10 participants at risk
400 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Refractory
n=3 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Sensitive
n=6 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Refractory Expansion
n=12 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg SCLC Sensitive Expansion
n=14 participants at risk
1000 mg IV BMS-986012 every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Refractory
n=2 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Sensitive
n=6 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Refractory Expansion
n=4 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 400mg + Nivo 360mg SCLC Sensitive Expansion
n=9 participants at risk
400 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg SCLC Refractory
n=3 participants at risk
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
BMS 1000mg + Nivo 360mg SCLC Sensitive
n=5 participants at risk
1000 mg IV BMS-986012 + 360 mg Nivolumab every 21 days until protocol-specified discontinuation criteria are met
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
6/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
70.0%
7/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
41.7%
5/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
42.9%
6/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
75.0%
3/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
41.7%
5/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
60.0%
6/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
21.4%
3/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
44.4%
4/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Face oedema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Ear and labyrinth disorders
Deafness
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Cataract
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Eye pruritus
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Eyelid pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Myopia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Ophthalmic vein thrombosis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Visual impairment
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Eye disorders
Vitreous floaters
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
30.0%
3/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
21.4%
3/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
41.7%
5/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
21.4%
3/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
44.4%
4/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
4/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
30.0%
3/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
58.3%
7/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
35.7%
5/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
44.4%
4/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
60.0%
3/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
30.0%
3/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
3/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
44.4%
4/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Asthenia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Axillary pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
21.4%
3/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Chest pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Chills
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Fatigue
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
75.0%
3/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
4/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
30.0%
3/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
3/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
58.3%
7/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
85.7%
12/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
4/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
44.4%
4/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Feeling cold
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Infusion site erythema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Infusion site pruritus
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Infusion site swelling
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Malaise
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Mucosal dryness
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Nodule
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Oedema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
4/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Pyrexia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Swelling face
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
General disorders
Thirst
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Immune system disorders
Dust allergy
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
44.4%
4/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Oral herpes
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Pustule
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Amylase increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Bacterial test positive
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Poor venous access
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Body temperature fluctuation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Body temperature increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Clostridium test positive
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
General physical condition abnormal
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Lipase increased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Streptococcus test positive
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Vitamin D decreased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Weight decreased
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Investigations
Weight increased
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
75.0%
3/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
4/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
9/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
60.0%
3/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
4/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
4/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
2/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
3/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Depressed level of consciousness
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
2/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Parosmia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Transient ischaemic attack
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Delirium
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
30.0%
3/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Reproductive system and breast disorders
Genital burning sensation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Reproductive system and breast disorders
Penile erythema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
21.4%
3/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
44.4%
4/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
21.4%
3/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
40.0%
2/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
21.4%
3/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
3/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
60.0%
3/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
22.2%
2/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Nail hypertrophy
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
4/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
2/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
2/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
3/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
4/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
12/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
80.0%
8/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
3/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
6/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
75.0%
9/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
92.9%
13/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
83.3%
5/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
4/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
9/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
3/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
100.0%
5/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
2/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
10.0%
1/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
3/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
14.3%
2/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
20.0%
1/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
50.0%
1/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
8.3%
1/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
7.1%
1/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
25.0%
1/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
30.0%
3/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
16.7%
2/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/10 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/12 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/14 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/2 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/4 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
11.1%
1/9 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/3 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
0.00%
0/5 • SAEs and Other AEs are assessed from first dose up to 100 days post last dose (Up to 64 months). Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 97 months).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: 855-907-3286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER