Trial Outcomes & Findings for A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02574078)
NCT ID: NCT02574078
Last Updated: 2021-05-06
Results Overview
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
341 participants
Primary outcome timeframe
up to approximately 48 months
Results posted on
2021-05-06
Participant Flow
341 participants were grouped as such: Groups A-D: 328 participants randomized, 314 treated and 14 not treated. Reasons not treated: Group A - 1 no longer met criteria; Group B - 3 withdrew consent, 2 no longer met criteria, 2 other; Group C - 1 no longer met criteria; Group D - 2 withdrew consent, 1 poor/non-compliance, 2 other. Group E: 13 participants treated.
Participant milestones
| Measure |
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
Best Supportive Care (BSC)
|
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Treatment Period
STARTED
|
13
|
6
|
9
|
35
|
34
|
35
|
18
|
17
|
26
|
26
|
53
|
56
|
13
|
|
Pre-Treatment Period
COMPLETED
|
13
|
6
|
9
|
35
|
34
|
34
|
14
|
14
|
25
|
26
|
49
|
55
|
13
|
|
Pre-Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
3
|
1
|
0
|
4
|
1
|
0
|
|
Treatment Period
STARTED
|
13
|
6
|
9
|
35
|
34
|
34
|
14
|
14
|
25
|
26
|
49
|
55
|
13
|
|
Treatment Period
COMPLETED
|
3
|
0
|
0
|
7
|
3
|
1
|
2
|
2
|
1
|
9
|
4
|
8
|
0
|
|
Treatment Period
NOT COMPLETED
|
10
|
6
|
9
|
28
|
31
|
33
|
12
|
12
|
24
|
17
|
45
|
47
|
13
|
Reasons for withdrawal
| Measure |
Group A, Cohort A, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
Best Supportive Care (BSC)
|
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Treatment Period
Participant no longer meets study criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Pre-Treatment Period
Participant withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
2
|
0
|
0
|
|
Pre-Treatment Period
Other reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Pre-Treatment Period
Poor/non-compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period
Disease progression
|
6
|
4
|
7
|
18
|
16
|
26
|
5
|
9
|
8
|
5
|
20
|
29
|
2
|
|
Treatment Period
Study drug toxicity
|
1
|
1
|
0
|
5
|
3
|
1
|
2
|
0
|
2
|
1
|
16
|
2
|
4
|
|
Treatment Period
Death
|
2
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
7
|
1
|
0
|
2
|
1
|
|
Treatment Period
Adverse event unrelated to drug
|
0
|
0
|
1
|
0
|
2
|
3
|
0
|
0
|
1
|
2
|
4
|
1
|
0
|
|
Treatment Period
Administrative reason by Sponsor
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Treatment Period
Other reasons
|
1
|
0
|
1
|
3
|
3
|
1
|
2
|
1
|
3
|
1
|
1
|
3
|
1
|
|
Treatment Period
Participant request to stop drug
|
0
|
0
|
0
|
2
|
4
|
0
|
1
|
0
|
3
|
2
|
2
|
4
|
1
|
|
Treatment Period
Participant withdrew consent
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
2
|
1
|
4
|
1
|
|
Treatment Period
Participant no longer meets criteria
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Treatment Period
Maximum clinical benefit
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Group A, Cohort A, Nivo
n=13 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
n=6 Participants
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
n=9 Participants
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
n=35 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
n=34 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
n=35 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
n=18 Participants
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
n=17 Participants
Best Supportive Care (BSC)
|
Group C, Nivo
n=26 Participants
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
n=26 Participants
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
n=53 Participants
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
n=56 Participants
Erlotinib 150 mg QD.
|
Group E
n=13 Participants
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
12 Participants
|
20 Participants
n=19 Participants
|
25 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
156 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
14 Participants
|
33 Participants
n=19 Participants
|
31 Participants
n=4 Participants
|
6 Participants
n=7 Participants
|
185 Participants
n=7 Participants
|
|
Age, Customized
< 65 years old
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
4 Participants
|
21 Participants
n=19 Participants
|
20 Participants
n=4 Participants
|
7 Participants
n=7 Participants
|
119 Participants
n=7 Participants
|
|
Age, Customized
>= 65 and < 75 years old
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
13 Participants
n=114 Participants
|
11 Participants
|
21 Participants
n=19 Participants
|
24 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
141 Participants
n=7 Participants
|
|
Age, Customized
>= 75 years old
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
10 Participants
n=114 Participants
|
11 Participants
|
11 Participants
n=19 Participants
|
12 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
81 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
3 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
32 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
26 Participants
n=114 Participants
|
23 Participants
|
50 Participants
n=19 Participants
|
51 Participants
n=4 Participants
|
13 Participants
n=7 Participants
|
320 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
9 Participants
n=19 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
22 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
4 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
22 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
34 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
23 Participants
n=114 Participants
|
21 Participants
|
41 Participants
n=19 Participants
|
43 Participants
n=4 Participants
|
10 Participants
n=7 Participants
|
288 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to approximately 48 monthsPopulation: All randomized participants in Groups A-D only
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Group A, Cohort A, Nivo
n=13 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
n=6 Participants
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
n=9 Participants
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
n=35 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
n=34 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
n=35 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
n=18 Participants
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
n=17 Participants
Best Supportive Care (BSC)
|
Group C, Nivo
n=26 Participants
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
n=26 Participants
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
n=53 Participants
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
n=56 Participants
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS), Groups A-D Only
|
15.0 Months
Interval 1.4 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
6.7 Months
Interval 4.1 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
6.0 Months
Interval 3.3 to 19.3
|
5.9 Months
Interval 2.6 to 12.9
|
8.1 Months
Interval 4.0 to 12.0
|
5.0 Months
Interval 2.1 to 6.8
|
9.6 Months
Interval 2.1 to 24.2
|
2.3 Months
Interval 1.0 to 4.0
|
2.7 Months
Interval 1.2 to 4.9
|
6.7 Months
Interval 4.4 to 13.1
|
11.0 Months
Interval 9.3 to 17.0
|
11.0 Months
Interval 7.6 to 13.0
|
—
|
PRIMARY outcome
Timeframe: up to approximately 60 monthsPopulation: All randomized participants in Groups A-C only
Overall survival (OS) is defined as the time from randomization to the date of death.
Outcome measures
| Measure |
Group A, Cohort A, Nivo
n=13 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
n=6 Participants
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
n=9 Participants
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
n=35 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
n=34 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
n=35 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
n=18 Participants
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
n=17 Participants
Best Supportive Care (BSC)
|
Group C, Nivo
n=26 Participants
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
n=26 Participants
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS), Groups A-C Only
|
20.0 Months
Interval 2.4 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
30.8 Months
Interval 8.8 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
18.1 Months
Interval 3.3 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
28.9 Months
Interval 14.8 to 38.3
|
17.4 Months
Interval 10.7 to 39.7
|
18.4 Months
Interval 6.7 to 30.9
|
NA Months
Interval 11.0 to
Median not reached as insufficient progression events among responders
|
13.6 Months
Interval 2.0 to 36.8
|
3.9 Months
Interval 1.5 to 12.5
|
15.8 Months
Interval 6.5 to 23.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: up to approximately 60 monthsPopulation: All treated participants in Group E only
Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.
Outcome measures
| Measure |
Group A, Cohort A, Nivo
n=13 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
Best Supportive Care (BSC)
|
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only
|
38.5 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 48 monthsPopulation: All responders (participants with objective response of CR or PR) in Groups A-D only.
Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Median computed using Kaplan-Meier method.
Outcome measures
| Measure |
Group A, Cohort A, Nivo
n=3 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
n=1 Participants
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
n=1 Participants
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
n=10 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
n=7 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
n=1 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
n=3 Participants
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
n=1 Participants
Best Supportive Care (BSC)
|
Group C, Nivo
n=5 Participants
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
n=4 Participants
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
n=33 Participants
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
n=35 Participants
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR), Groups A-D Only
|
12.780 months
Interval 4.14 to 20.435
|
NA months
Median not reached as insufficient progression events among responders
|
17.084 months
only 1 participant
|
12.912 months
Interval 1.873 to 31.113
|
8.542 months
Interval 2.464 to 9.265
|
14.982 months
only 1 participant
|
NA months
Interval 11.072 to
Median not reached as insufficient progression events among responders
|
NA months
Median not reached as insufficient progression events among responders
|
3.877 months
Interval 2.103 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
2.940 months
Interval 1.577 to 4.304
|
8.805 months
Interval 5.52 to 13.437
|
10.152 months
Interval 5.552 to 17.314
|
—
|
SECONDARY outcome
Timeframe: up to approximately 48 monthsPopulation: All randomized (Groups A-D) and treated (Group E) participants with at least one lesion at baseline
Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. Confidence interval based on the Clopper and Pearson method.
Outcome measures
| Measure |
Group A, Cohort A, Nivo
n=13 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
n=6 Participants
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
n=8 Participants
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
n=34 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
n=33 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
n=32 Participants
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
n=16 Participants
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
n=17 Participants
Best Supportive Care (BSC)
|
Group C, Nivo
n=24 Participants
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
n=26 Participants
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
n=51 Participants
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
n=56 Participants
Erlotinib 150 mg QD.
|
Group E
n=13 Participants
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR), Groups A-E
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
29.4 Percentage of participants
Interval 15.1 to 47.5
|
21.2 Percentage of participants
Interval 9.0 to 38.9
|
3.1 Percentage of participants
Interval 0.1 to 16.2
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
20.8 Percentage of participants
Interval 7.1 to 42.2
|
15.4 Percentage of participants
Interval 4.4 to 34.9
|
64.7 Percentage of participants
Interval 50.1 to 77.6
|
62.5 Percentage of participants
Interval 48.5 to 75.1
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
SECONDARY outcome
Timeframe: up to approximately 60 monthsPopulation: All randomized participants in Group D only
Overall survival (OS) is defined as the time from randomization to the date of death.
Outcome measures
| Measure |
Group A, Cohort A, Nivo
n=53 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
n=56 Participants
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
Best Supportive Care (BSC)
|
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS), Group D Only
|
NA months
Interval 23.1 to
Median not reached as insufficient progression events among responders
|
34.8 months
Interval 22.5 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to approximately 48 monthsPopulation: All treated participants in Group E only
Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Group A, Cohort A, Nivo
n=13 Participants
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort A, Beva + Nivo
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort A, Beva
Bevacizumab 15 mg/kg every 3 weeks.
|
Group A, Cohort B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group A, Cohort B, Peme + Nivo
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
Group A, Cohort B, Peme
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
Group B, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group B, BSC
Best Supportive Care (BSC)
|
Group C, Nivo
Nivolumab 240 mg every 2 weeks.
|
Group C, ICC
Investigator's Choice of Chemotherapy
|
Group D, Nivo + Erlo
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
Group D, Erlo
Erlotinib 150 mg QD.
|
Group E
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS), Group E Only
|
9.63 months
Interval 0.95 to 20.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SUB-STUDY A, COHORT A: NIVOLUMAB 240 MG
Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths
SUB-STUDY A: BEVACIZUMAB + NIVOLUMAB 5 MG/KG
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
SUB-STUDY A: BEVACIZUMAB
Serious events: 5 serious events
Other events: 9 other events
Deaths: 6 deaths
SUB-STUDY A, COHORT B: NIVOLUMAB 240 MG
Serious events: 15 serious events
Other events: 35 other events
Deaths: 24 deaths
SUB-STUDY A: PEMETREXED + NIVOLUMAB 5 MG/KG
Serious events: 16 serious events
Other events: 32 other events
Deaths: 23 deaths
SUB-STUDY A: PEMETREXED
Serious events: 14 serious events
Other events: 33 other events
Deaths: 24 deaths
SUB-STUDY B: NIVOLUMAB 240 MG
Serious events: 5 serious events
Other events: 13 other events
Deaths: 5 deaths
SUB-STUDY B: BEST SUPPORTIVE CARE
Serious events: 7 serious events
Other events: 13 other events
Deaths: 9 deaths
SUB-STUDY C: NIVOLUMAB 240 MG
Serious events: 23 serious events
Other events: 22 other events
Deaths: 23 deaths
SUB-STUDY C: INVESTIGATOR'S CHOICE OF CHEMOTHERAPY
Serious events: 7 serious events
Other events: 25 other events
Deaths: 18 deaths
SUB-STUDY D: NIVOLUMAB 240 MG + ERLOTINIB
Serious events: 25 serious events
Other events: 49 other events
Deaths: 20 deaths
SUB-STUDY D: ERLOTINIB
Serious events: 17 serious events
Other events: 55 other events
Deaths: 25 deaths
SUB-STUDY E: SINGLE ARM: NIVOLUMAB 240 MG + CRIZOTINIB
Serious events: 8 serious events
Other events: 13 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
SUB-STUDY A, COHORT A: NIVOLUMAB 240 MG
n=13 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY A: BEVACIZUMAB + NIVOLUMAB 5 MG/KG
n=6 participants at risk
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
SUB-STUDY A: BEVACIZUMAB
n=9 participants at risk
Bevacizumab 15 mg/kg every 3 weeks.
|
SUB-STUDY A, COHORT B: NIVOLUMAB 240 MG
n=35 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY A: PEMETREXED + NIVOLUMAB 5 MG/KG
n=34 participants at risk
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
SUB-STUDY A: PEMETREXED
n=34 participants at risk
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
SUB-STUDY B: NIVOLUMAB 240 MG
n=14 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY B: BEST SUPPORTIVE CARE
n=14 participants at risk
Best Supportive Care (BSC)
|
SUB-STUDY C: NIVOLUMAB 240 MG
n=25 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY C: INVESTIGATOR'S CHOICE OF CHEMOTHERAPY
n=26 participants at risk
Investigator's Choice of Chemotherapy (ICC)
|
SUB-STUDY D: NIVOLUMAB 240 MG + ERLOTINIB
n=49 participants at risk
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
SUB-STUDY D: ERLOTINIB
n=55 participants at risk
Erlotinib 150 mg QD.
|
SUB-STUDY E: SINGLE ARM: NIVOLUMAB 240 MG + CRIZOTINIB
n=13 participants at risk
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Asthenia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Chills
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Incarcerated hernia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Hepatobiliary disorders
Bile duct obstruction
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Abscess
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Cyclosporidium infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Cytomegalovirus gastrointestinal infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Empyema
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Paraspinal abscess
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
3/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.5%
3/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Wound infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood glucose increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Liver function test increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
28.6%
4/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
32.0%
8/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Encephalopathy
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Myasthenia gravis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
Other adverse events
| Measure |
SUB-STUDY A, COHORT A: NIVOLUMAB 240 MG
n=13 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY A: BEVACIZUMAB + NIVOLUMAB 5 MG/KG
n=6 participants at risk
Bevacizumab 15 mg/kg + nivolumab 5 mg/kg every 3 weeks.
|
SUB-STUDY A: BEVACIZUMAB
n=9 participants at risk
Bevacizumab 15 mg/kg every 3 weeks.
|
SUB-STUDY A, COHORT B: NIVOLUMAB 240 MG
n=35 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY A: PEMETREXED + NIVOLUMAB 5 MG/KG
n=34 participants at risk
Pemetrexed 500 mg/m\^2 every 3 weeks + nivolumab 5 mg/kg every 3 weeks.
|
SUB-STUDY A: PEMETREXED
n=34 participants at risk
Pemetrexed 500 mg/m\^2 every 3 weeks.
|
SUB-STUDY B: NIVOLUMAB 240 MG
n=14 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY B: BEST SUPPORTIVE CARE
n=14 participants at risk
Best Supportive Care (BSC)
|
SUB-STUDY C: NIVOLUMAB 240 MG
n=25 participants at risk
Nivolumab 240 mg every 2 weeks.
|
SUB-STUDY C: INVESTIGATOR'S CHOICE OF CHEMOTHERAPY
n=26 participants at risk
Investigator's Choice of Chemotherapy (ICC)
|
SUB-STUDY D: NIVOLUMAB 240 MG + ERLOTINIB
n=49 participants at risk
Nivolumab 240 mg every 2 weeks + erlotinib 150 mg once a day (QD).
|
SUB-STUDY D: ERLOTINIB
n=55 participants at risk
Erlotinib 150 mg QD.
|
SUB-STUDY E: SINGLE ARM: NIVOLUMAB 240 MG + CRIZOTINIB
n=13 participants at risk
Nivolumab 240 mg every 2 weeks + crizotinib 250 mg two times a day (BID).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Bladder diverticulum
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Paronychia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
32.4%
11/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.5%
8/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
19.2%
5/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
32.7%
16/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.2%
10/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
30.8%
8/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
19.2%
5/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.1%
6/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
7/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.7%
7/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Eye disorders
Photopsia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Eye disorders
Vision blurred
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Eye disorders
Visual impairment
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
24.0%
6/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.2%
6/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.9%
6/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.1%
6/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.6%
7/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
28.6%
4/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
5/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
19.2%
5/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.3%
8/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.2%
10/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
46.2%
6/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
50.0%
3/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
55.6%
5/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
37.1%
13/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
26.5%
9/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
35.7%
5/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
28.0%
7/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
34.6%
9/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
67.3%
33/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
65.5%
36/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.7%
5/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Dysphagia
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
7/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.5%
8/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
26.5%
9/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
32.0%
8/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
38.5%
10/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
49.0%
24/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
38.2%
21/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
46.2%
6/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Oesophageal spasm
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.4%
10/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.4%
9/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.0%
4/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
4/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.4%
10/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.2%
10/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
30.8%
4/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Asthenia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Axillary pain
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Chest discomfort
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Chills
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Cyst
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Fatigue
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
45.7%
16/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
38.2%
13/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
32.4%
11/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
35.7%
5/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
32.0%
8/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
26.9%
7/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
51.0%
25/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
41.8%
23/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
61.5%
8/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Gait disturbance
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Generalised oedema
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Influenza like illness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Localised oedema
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Mass
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Mucosal pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Oedema peripheral
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
41.2%
14/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.5%
8/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
5/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
19.2%
5/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
28.6%
14/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.9%
6/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
38.5%
5/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Peripheral swelling
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
5/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.6%
6/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
7/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
30.8%
4/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
General disorders
Swelling
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Hepatobiliary disorders
Hepatitis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Device related infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Endocarditis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Fungal infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.6%
6/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.7%
7/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.2%
6/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
5/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
7/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.9%
6/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
53.8%
7/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.2%
6/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.9%
6/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
46.2%
6/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Blood urea increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.5%
3/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Protein total decreased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Transaminases increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Troponin I increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Troponin increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Weight decreased
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.1%
6/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.0%
4/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
4/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.3%
8/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
Weight increased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
3/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.1%
6/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
32.4%
11/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
24.0%
6/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
26.9%
7/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
30.6%
15/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
38.2%
21/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
26.9%
7/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.4%
10/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
5/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.6%
6/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.3%
8/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.2%
10/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.6%
6/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.5%
3/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.3%
8/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.5%
8/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Malnutrition
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Vitamin C deficiency
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.9%
8/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.4%
11/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.8%
4/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.7%
5/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
5/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
7/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.7%
7/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
5/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.2%
4/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.6%
6/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.7%
7/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.7%
5/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.4%
11/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Drooling
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.5%
8/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Facial paresis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.9%
8/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.3%
8/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Product Issues
Device occlusion
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
5/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
5/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.2%
6/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
5/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.4%
9/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
9.1%
5/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
33.3%
2/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
66.7%
4/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
7/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.6%
7/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.6%
7/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
21.4%
3/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.0%
4/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.4%
11/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
25.5%
14/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
30.8%
4/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
28.6%
10/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.7%
5/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.6%
6/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
5/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.4%
9/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.2%
10/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
12.0%
3/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.4%
4/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.9%
6/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.8%
3/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
23.1%
3/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Use of accessory respiratory muscles
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
7/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.2%
10/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
46.9%
23/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
52.7%
29/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
11/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
2/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.7%
5/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
28.6%
14/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.5%
8/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
17.1%
6/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.8%
1/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.4%
9/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
20.0%
11/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.8%
4/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
7/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
18.2%
10/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.0%
1/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.5%
3/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.7%
2/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
4.1%
2/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
16.7%
1/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
22.2%
2/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.6%
3/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
14.3%
2/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
6.1%
3/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.3%
4/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
5.9%
2/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
8.0%
2/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
2/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
10.2%
5/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
3.6%
2/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Jugular vein distension
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Jugular vein thrombosis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.0%
1/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
7.1%
1/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Subclavian vein thrombosis
|
7.7%
1/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/6 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
11.1%
1/9 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/35 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
2.9%
1/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/34 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/14 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/25 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/26 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/49 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
1.8%
1/55 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
0.00%
0/13 • Treated population: From first dose to 100 days post last dose (approximately 60 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60