Trial Outcomes & Findings for Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors (NCT NCT02052648)
NCT ID: NCT02052648
Last Updated: 2024-03-27
Results Overview
Number of RLTs observed in each dose level.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
160 participants
Primary outcome timeframe
3 months
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Level 1
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
80
|
28
|
40
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
80
|
28
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
n=3 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
n=6 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
n=80 Participants
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
n=28 Participants
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
n=40 Participants
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
112 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 4.04 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 12.66 • n=7 Participants
|
48.0 years
STANDARD_DEVIATION 11.14 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 13.69 • n=4 Participants
|
54.0 years
STANDARD_DEVIATION 14.64 • n=21 Participants
|
56.8 years
STANDARD_DEVIATION 12.20 • n=8 Participants
|
55.2 years
STANDARD_DEVIATION 13.36 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
68 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
92 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
145 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
149 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
ECOG Performance Status Scale
ECOG = 0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
70 Participants
n=8 Participants
|
|
ECOG Performance Status Scale
ECOG = 1
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
|
ECOG Performance Status Scale
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Mean Height
|
176.667 Centimeters
STANDARD_DEVIATION 12.6623 • n=5 Participants
|
179.133 Centimeters
STANDARD_DEVIATION 5.5185 • n=7 Participants
|
171.720 Centimeters
STANDARD_DEVIATION 8.8797 • n=5 Participants
|
172.505 Centimeters
STANDARD_DEVIATION 9.8244 • n=4 Participants
|
168.710 Centimeters
STANDARD_DEVIATION 9.3381 • n=21 Participants
|
173.659 Centimeters
STANDARD_DEVIATION 10.1278 • n=8 Participants
|
172.302 Centimeters
STANDARD_DEVIATION 9.839 • n=8 Participants
|
|
Mean Weight
|
96.467 Kilograms
STANDARD_DEVIATION 22.7315 • n=5 Participants
|
103.117 Kilograms
STANDARD_DEVIATION 22.9877 • n=7 Participants
|
81.083 Kilograms
STANDARD_DEVIATION 25.0460 • n=5 Participants
|
83.342 Kilograms
STANDARD_DEVIATION 17.5121 • n=4 Participants
|
75.882 Kilograms
STANDARD_DEVIATION 11.5149 • n=21 Participants
|
84.649 Kilograms
STANDARD_DEVIATION 19.2743 • n=8 Participants
|
82.895 Kilograms
STANDARD_DEVIATION 17.881 • n=8 Participants
|
|
Mean BMI
|
31.807 kg/m2
STANDARD_DEVIATION 11.9796 • n=5 Participants
|
31.967 kg/m2
STANDARD_DEVIATION 5.1495 • n=7 Participants
|
27.260 kg/m2
STANDARD_DEVIATION 7.894 • n=5 Participants
|
27.904 kg/m2
STANDARD_DEVIATION 5.1508 • n=4 Participants
|
26.633 kg/m2
STANDARD_DEVIATION 3.5701 • n=21 Participants
|
28.037 kg/m2
STANDARD_DEVIATION 6.0775 • n=8 Participants
|
27.84 kg/m2
STANDARD_DEVIATION 5.42 • n=8 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of RLTs observed in each dose level.
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
n=3 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
n=6 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
|---|---|---|---|---|---|---|
|
Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsSix-month progression-free survival.
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=77 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
n=28 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
n=39 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
|---|---|---|---|---|---|---|
|
Phase 2: Number of Phase 1 Participants With Efficacy Outcomes
|
18.6 Percent
Interval 10.4 to 28.8
|
3.9 Percent
Interval 0.3 to 16.6
|
22.9 Percent
Interval 10.5 to 38.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsSubjects with a complete response or partial response by RANO assessment. Overall Response Rate was only assessed in phase 2 subjects on this trial.
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=77 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
n=28 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
n=39 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate for Phase 2 Participants
|
5.2 Percent
Interval 1.4 to 12.8
|
0 Percent
Interval 0.0 to 12.3
|
7.7 Percent
Interval 1.6 to 20.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 MonthsNumber of subjects with at least 1 treatment emergent adverse event.
Outcome measures
| Measure |
Phase 1 Dose Level 1
n=3 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
n=3 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
n=6 Participants
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
n=77 Participants
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
n=28 Participants
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
n=39 Participants
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
3 Participants
|
3 Participants
|
6 Participants
|
72 Participants
|
27 Participants
|
39 Participants
|
Adverse Events
Phase 1 Dose Level 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1 Dose Level 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1 Dose Level 3
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 2 Cohort 2a
Serious events: 21 serious events
Other events: 77 other events
Deaths: 67 deaths
Phase 2 Cohort 2b
Serious events: 10 serious events
Other events: 28 other events
Deaths: 28 deaths
Phase 2 Cohort 2c
Serious events: 17 serious events
Other events: 39 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
n=3 participants at risk
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
n=6 participants at risk
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
n=77 participants at risk
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
n=28 participants at risk
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
n=39 participants at risk
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
15.4%
6/39 • Number of events 6 • Up to 36 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
syncope
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
Other adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
Phase 1 Cohort 1 patients will receive Indoximod given at 600 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 2
n=3 participants at risk
Phase 1 Cohort 1 patients will receive Indoximod given at 1000 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 1 Dose Level 3
n=6 participants at risk
Phase 1 Cohort 1 patients will receive Indoximod given at 1200 mg BID by mouth Temozolomide will also be given by mouth at 150 mg/m\^2 x 5 days
|
Phase 2 Cohort 2a
n=77 participants at risk
Bevacizumab naïve phase II patients who will receive indoximod with temozolomide. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2.
|
Phase 2 Cohort 2b
n=28 participants at risk
Phase II patients who will receive indoximod with temozolomide and bevacizumab who have previously been treated with bevacizumab.
Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Bevacizumab will be dosed at 10mg/kg.
|
Phase 2 Cohort 2c
n=39 participants at risk
Phase II patients who will receive indoximod with temozolomide and stereotactic radiosurgery. Indoximod will be dosed at 1200mg BID. Temozolomide will be dosed at 150 mg/m2 and may be escalated up to 200 mg/m2. Single fraction SRS dose will be 16 or 20 Gy depending on target volume. The total 5-fraction SRT dose will be 27.5 Gy.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Mania
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 36 months.
|
66.7%
2/3 • Number of events 2 • Up to 36 months.
|
66.7%
4/6 • Number of events 4 • Up to 36 months.
|
28.6%
22/77 • Number of events 22 • Up to 36 months.
|
25.0%
7/28 • Number of events 7 • Up to 36 months.
|
48.7%
19/39 • Number of events 19 • Up to 36 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 36 months.
|
66.7%
2/3 • Number of events 2 • Up to 36 months.
|
33.3%
2/6 • Number of events 2 • Up to 36 months.
|
16.9%
13/77 • Number of events 13 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
12.8%
5/39 • Number of events 5 • Up to 36 months.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
15.6%
12/77 • Number of events 12 • Up to 36 months.
|
10.7%
3/28 • Number of events 3 • Up to 36 months.
|
20.5%
8/39 • Number of events 8 • Up to 36 months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
33.3%
2/6 • Number of events 2 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
13.0%
10/77 • Number of events 10 • Up to 36 months.
|
17.9%
5/28 • Number of events 5 • Up to 36 months.
|
23.1%
9/39 • Number of events 9 • Up to 36 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
33.3%
2/6 • Number of events 2 • Up to 36 months.
|
11.7%
9/77 • Number of events 9 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
11.7%
9/77 • Number of events 9 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
30.8%
12/39 • Number of events 12 • Up to 36 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
7.8%
6/77 • Number of events 6 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
17.9%
7/39 • Number of events 7 • Up to 36 months.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Neurologic neglect syndrome
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Nervous system disorders
Aura
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Clonus
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Diplegia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Dyscalculia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Up to 36 months.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
10.7%
3/28 • Number of events 3 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Upper motor neurone lesion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Drooling
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Nervous system disorders
Postictal paralysis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Tardive dyskinesia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Up to 36 months.
|
100.0%
3/3 • Up to 36 months.
|
66.7%
4/6 • Up to 36 months.
|
70.1%
54/77 • Up to 36 months.
|
67.9%
19/28 • Up to 36 months.
|
53.8%
21/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Up to 36 months.
|
33.3%
1/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
44.2%
34/77 • Number of events 34 • Up to 36 months.
|
25.0%
7/28 • Number of events 7 • Up to 36 months.
|
51.3%
20/39 • Number of events 20 • Up to 36 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to 36 months.
|
100.0%
3/3 • Up to 36 months.
|
66.7%
4/6 • Up to 36 months.
|
32.5%
25/77 • Number of events 25 • Up to 36 months.
|
28.6%
8/28 • Number of events 8 • Up to 36 months.
|
35.9%
14/39 • Number of events 14 • Up to 36 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Up to 36 months.
|
16.7%
1/6 • Up to 36 months.
|
10.4%
8/77 • Number of events 8 • Up to 36 months.
|
14.3%
4/28 • Number of events 4 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
10.7%
3/28 • Number of events 3 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
15.4%
6/39 • Number of events 6 • Up to 36 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Proctitis
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Nervous system disorders
Colitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
33.3%
2/6 • Number of events 2 • Up to 36 months.
|
40.3%
31/77 • Number of events 31 • Up to 36 months.
|
32.1%
9/28 • Number of events 9 • Up to 36 months.
|
53.8%
21/39 • Number of events 21 • Up to 36 months.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
14.3%
4/28 • Number of events 4 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
6.5%
5/77 • Number of events 5 • Up to 36 months.
|
10.7%
3/28 • Number of events 3 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
14.3%
11/77 • Number of events 11 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
12.8%
5/39 • Number of events 5 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
9.1%
7/77 • Number of events 7 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
12.8%
5/39 • Number of events 5 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
11.7%
9/77 • Number of events 9 • Up to 36 months.
|
14.3%
4/28 • Number of events 4 • Up to 36 months.
|
12.8%
5/39 • Number of events 5 • Up to 36 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
9.1%
7/77 • Number of events 7 • Up to 36 months.
|
10.7%
3/28 • Number of events 3 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Swelling
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
10.4%
8/77 • Number of events 8 • Up to 36 months.
|
14.3%
4/28 • Number of events 4 • Up to 36 months.
|
28.2%
11/39 • Number of events 11 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
6.5%
5/77 • Number of events 5 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
7.8%
6/77 • Number of events 6 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
7.8%
6/77 • Number of events 6 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 2 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
6.5%
5/77 • Up to 36 months.
|
3.6%
1/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
15.4%
6/39 • Number of events 6 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
15.4%
6/39 • Number of events 6 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary necrosis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
7.8%
6/77 • Number of events 6 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
33.3%
2/6 • Number of events 2 • Up to 36 months.
|
9.1%
7/77 • Number of events 7 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
23.1%
9/39 • Number of events 9 • Up to 36 months.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
7.8%
6/77 • Number of events 6 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
6.5%
5/77 • Number of events 5 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Psychiatric disorders
Abulia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Psychiatric disorders
Frustration tolerance
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Psychiatric disorders
Phonophobia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Up to 36 months.
|
|
Psychiatric disorders
Hallucination,Visual
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Up to 36 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
11.7%
9/77 • Number of events 9 • Up to 36 months.
|
17.9%
5/28 • Number of events 5 • Up to 36 months.
|
20.5%
8/39 • Number of events 8 • Up to 36 months.
|
|
Psychiatric disorders
Mood altered
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
9.1%
7/77 • Number of events 7 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
16.7%
1/6 • Number of events 1 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to 36 months.
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
20.5%
8/39 • Number of events 8 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
17.9%
7/39 • Number of events 7 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
12.8%
5/39 • Number of events 5 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • Number of events 2 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
7.1%
2/28 • Number of events 2 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Post procedural persistent drain fluid
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Incision site pain s
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Procedural anxiety
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
23.4%
18/77 • Number of events 18 • Up to 36 months.
|
25.0%
7/28 • Number of events 7 • Up to 36 months.
|
23.1%
9/39 • Number of events 9 • Up to 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Renal and urinary disorders
Micturition urgency
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Renal and urinary disorders
Nocturia
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
33.3%
1/3 • Number of events 1 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
6.5%
5/77 • Number of events 5 • Up to 36 months.
|
14.3%
4/28 • Number of events 4 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 12 • Up to 36 months.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
10.4%
8/77 • Number of events 8 • Up to 36 months.
|
10.7%
3/28 • Number of events 3 • Up to 36 months.
|
5.1%
2/39 • Number of events 2 • Up to 36 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
9.1%
7/77 • Number of events 7 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
12.8%
5/39 • Number of events 5 • Up to 36 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
16.9%
13/77 • Number of events 13 • Up to 36 months.
|
14.3%
4/28 • Number of events 4 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
9.1%
7/77 • Number of events 7 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
9.1%
7/77 • Number of events 7 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
7.7%
3/39 • Number of events 3 • Up to 36 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
5.2%
4/77 • Number of events 4 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
3.9%
3/77 • Number of events 3 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
10.3%
4/39 • Number of events 4 • Up to 36 months.
|
|
Investigations
Alanine aminotransferase increase
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
2.6%
2/77 • Number of events 2 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Blood creatine phosphokinase increased blood
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
3.6%
1/28 • Number of events 1 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
1.3%
1/77 • Number of events 1 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
0.00%
0/39 • Up to 36 months.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
|
Investigations
Head lag abnormal
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/3 • Up to 36 months.
|
0.00%
0/6 • Up to 36 months.
|
0.00%
0/77 • Up to 36 months.
|
0.00%
0/28 • Up to 36 months.
|
2.6%
1/39 • Number of events 1 • Up to 36 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60