Trial Outcomes & Findings for Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma (NCT NCT02073123)
NCT ID: NCT02073123
Last Updated: 2026-05-29
Results Overview
Number subjects with at least one RLTs observed in each dose level.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
131 participants
Primary outcome timeframe
6 weeks
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
Phase 1: Indoximod 600mg + Ipilumumab
Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 1: Indoximod 1200mg + Ipilumumab
Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 2: Indoximod + Nivolumab
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Nivolumab: Nivolumab administered intravenously at 240 mg every 2 weeks.
|
Phase 2: Indoximod + Ipilimumab
Indoximod and ipilimumab will be dosed concurrently. Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1). Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles. Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
|
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Pembrolizumab: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
|---|---|---|---|---|---|
|
Phase 1
STARTED
|
3
|
6
|
0
|
0
|
0
|
|
Phase 1
COMPLETED
|
3
|
6
|
0
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
4
|
4
|
114
|
|
Phase 2
COMPLETED
|
0
|
0
|
4
|
4
|
114
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Phase 1: Indoximod 600mg + Ipilumumab
n=3 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 1: Indoximod 1200mg + Ipilumumab
n=6 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 2: Indoximod + Ipilimumab
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
|
Phase 2: Indoximod + Nivolumab
n=4 Participants
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth.
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity.
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Nivolumab: Nivolumab administered intravenously at 240 mg every 2 weeks.
|
Phase 2: Indoximod + Pembrolizumab
n=114 Participants
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth.
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1.
Pembrolizumab: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.67 years
STANDARD_DEVIATION 13.43 • n=51 Participants
|
64.17 years
STANDARD_DEVIATION 12.51 • n=14 Participants
|
70.0 years
STANDARD_DEVIATION 9.80 • n=65 Participants
|
73.8 years
STANDARD_DEVIATION 16.82 • n=57 Participants
|
62.5 years
STANDARD_DEVIATION 13.93 • n=39 Participants
|
62.9 years
STANDARD_DEVIATION 13.90 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=57 Participants
|
41 Participants
n=39 Participants
|
46 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
3 Participants
n=57 Participants
|
73 Participants
n=39 Participants
|
85 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
3 Participants
n=57 Participants
|
113 Participants
n=39 Participants
|
129 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
4 Participants
n=57 Participants
|
112 Participants
n=39 Participants
|
129 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=51 Participants
|
6 participants
n=14 Participants
|
4 participants
n=65 Participants
|
4 participants
n=57 Participants
|
114 participants
n=39 Participants
|
131 participants
n=3 Participants
|
|
Weight
|
84.49 Kilograms
STANDARD_DEVIATION 11.53 • n=51 Participants
|
83.65 Kilograms
STANDARD_DEVIATION 15.76 • n=14 Participants
|
77.400 Kilograms
STANDARD_DEVIATION 16.9615 • n=65 Participants
|
77.175 Kilograms
STANDARD_DEVIATION 6.8251 • n=57 Participants
|
89.516 Kilograms
STANDARD_DEVIATION 20.6127 • n=39 Participants
|
88.343 Kilograms
STANDARD_DEVIATION 20.1134 • n=3 Participants
|
|
Height
|
170.67 centimeters
STANDARD_DEVIATION 10.06 • n=51 Participants
|
172.38 centimeters
STANDARD_DEVIATION 6.34 • n=14 Participants
|
172.7 centimeters
STANDARD_DEVIATION 10.96 • n=65 Participants
|
171.9 centimeters
STANDARD_DEVIATION 7.86 • n=57 Participants
|
172.8 centimeters
STANDARD_DEVIATION 9.26 • n=39 Participants
|
172.7 centimeters
STANDARD_DEVIATION 9.05 • n=3 Participants
|
|
BMI
|
28.8 kg/m2
STANDARD_DEVIATION 5.75 • n=51 Participants
|
28.04 kg/m2
STANDARD_DEVIATION 4.11 • n=14 Participants
|
25.6 kg/m2
STANDARD_DEVIATION 2.86 • n=65 Participants
|
26.2 kg/m2
STANDARD_DEVIATION 3.24 • n=57 Participants
|
30.0 kg/m2
STANDARD_DEVIATION 6.60 • n=39 Participants
|
29.6 kg/m2
STANDARD_DEVIATION 6.37 • n=3 Participants
|
|
BSA
|
1.99 m2
STANDARD_DEVIATION 0.29 • n=51 Participants
|
2.0 m2
STANDARD_DEVIATION 0.21 • n=14 Participants
|
1.9 m2
STANDARD_DEVIATION 0.27 • n=65 Participants
|
1.9 m2
STANDARD_DEVIATION 0.10 • n=57 Participants
|
2.1 m2
STANDARD_DEVIATION 0.26 • n=39 Participants
|
2.0 m2
STANDARD_DEVIATION 0.26 • n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
|
.3 units on a scale
STANDARD_DEVIATION 0.58 • n=51 Participants
|
0.3 units on a scale
STANDARD_DEVIATION 0.52 • n=14 Participants
|
0.3 units on a scale
STANDARD_DEVIATION 0.50 • n=65 Participants
|
0.3 units on a scale
STANDARD_DEVIATION 0.50 • n=57 Participants
|
0.2 units on a scale
STANDARD_DEVIATION 0.43 • n=39 Participants
|
0.2 units on a scale
STANDARD_DEVIATION 0.43 • n=3 Participants
|
|
American Joint Committee on Cancer (AJCC) staging
IIIA
|
0 participants
n=51 Participants
|
0 participants
n=14 Participants
|
0 participants
n=65 Participants
|
0 participants
n=57 Participants
|
1 participants
n=39 Participants
|
1 participants
n=3 Participants
|
|
American Joint Committee on Cancer (AJCC) staging
IIIB
|
0 participants
n=51 Participants
|
0 participants
n=14 Participants
|
0 participants
n=65 Participants
|
0 participants
n=57 Participants
|
3 participants
n=39 Participants
|
3 participants
n=3 Participants
|
|
American Joint Committee on Cancer (AJCC) staging
IIIC
|
0 participants
n=51 Participants
|
0 participants
n=14 Participants
|
0 participants
n=65 Participants
|
0 participants
n=57 Participants
|
5 participants
n=39 Participants
|
5 participants
n=3 Participants
|
|
American Joint Committee on Cancer (AJCC) staging
IV
|
3 participants
n=51 Participants
|
6 participants
n=14 Participants
|
4 participants
n=65 Participants
|
4 participants
n=57 Participants
|
105 participants
n=39 Participants
|
122 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 6 weeksNumber subjects with at least one RLTs observed in each dose level.
Outcome measures
| Measure |
Phase 2: Indoximod + Pembrolizumab
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
Phase 1: Dose Level 1
n=3 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 600mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
Phase 1: Dose Level 2
n=6 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 1200mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
|---|---|---|---|
|
Phase 1 Regimen Limiting Toxicity of the Combination of Indoximod and Ipilimumab
|
—
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 22 monthsPhase 2 component: To evaluate the preliminary efficacy of the established dose of indoximod in combination with immune checkpoint inhibition as measured by the best overall response rate in patients with unresectable Stage III or Stage IV melanoma.
Outcome measures
| Measure |
Phase 2: Indoximod + Pembrolizumab
n=114 Participants
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
Phase 1: Dose Level 1
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 600mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
Phase 1: Dose Level 2
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 1200mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
|---|---|---|---|
|
Overall Response Rate
Complete Response
|
18 Participants
|
0 Participants
|
0 Participants
|
|
Overall Response Rate
Partial Response
|
29 Participants
|
0 Participants
|
1 Participants
|
|
Overall Response Rate
No Response
|
67 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: It was pre-specified to assess this Outcome Measure for Phase 2 Arm/Groups only.
Phase 2 component: Overall survival (OS) and 95% confidence interval
Outcome measures
| Measure |
Phase 2: Indoximod + Pembrolizumab
n=114 Participants
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
Phase 1: Dose Level 1
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 600mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
Phase 1: Dose Level 2
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 1200mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
|---|---|---|---|
|
Overall Survival
|
NA weeks
Interval 94.0 to
Not enough events (deaths) to statistically calculate the median and upper limit of confidence interval
|
29.8 weeks
Interval 23.3 to 91.4
|
94.65 weeks
Interval 77.4 to 122.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: It was pre-specified to assess this Outcome Measure for Phase 2 Arm/Groups only.
Phase 2 component: Time to progression with the combination indoximod with checkpoint inhibitor. Progression will be evaluated in this study using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).
Outcome measures
| Measure |
Phase 2: Indoximod + Pembrolizumab
n=75 Participants
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
Phase 1: Dose Level 1
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 600mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
Phase 1: Dose Level 2
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 1200mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
|---|---|---|---|
|
Progression Free Survival
|
43.9 Weeks
Interval 20.0 to 57.4
|
13.55 Weeks
Interval 12.3 to 23.3
|
17.8 Weeks
Interval 6.4 to 99.3
|
SECONDARY outcome
Timeframe: 22 monthsPopulation: It was pre-specified to assess this Outcome Measure for Phase 2 Arm/Groups only.
Phase 2 component: Disease control rate (CR, PR or SD)
Outcome measures
| Measure |
Phase 2: Indoximod + Pembrolizumab
n=114 Participants
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
Phase 1: Dose Level 1
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 600mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
Phase 1: Dose Level 2
n=4 Participants
Indoximod and ipilimumab will be dosed concurrently.
Indoximod 1200mg BID by mouth
Ipilimumab 3mg/kg Q3 weeks x 4 doses
|
|---|---|---|---|
|
Disease Control Rate
|
68 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Phase 1: Indoximod 600mg + Ipilumumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: Indoximod 1200mg + Ipilumumab
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2: Indoximod + Ipilimumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2: Indoximod + Nivolumab
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2: Indoximod + Pembrolizumab
Serious events: 39 serious events
Other events: 114 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1: Indoximod 600mg + Ipilumumab
n=3 participants at risk
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 1: Indoximod 1200mg + Ipilumumab
n=6 participants at risk
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 2: Indoximod + Ipilimumab
n=4 participants at risk
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
|
Phase 2: Indoximod + Nivolumab
n=4 participants at risk
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Nivolumab: Nivolumab administered intravenously at 240 mg every 2 weeks.
|
Phase 2: Indoximod + Pembrolizumab
n=114 participants at risk
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Pembrolizumab: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Device related thrombosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Pneumatosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
Other adverse events
| Measure |
Phase 1: Indoximod 600mg + Ipilumumab
n=3 participants at risk
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 1: Indoximod 1200mg + Ipilumumab
n=6 participants at risk
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
|
Phase 2: Indoximod + Ipilimumab
n=4 participants at risk
Indoximod and ipilimumab will be dosed concurrently.
Indoximod will be dosed twice daily on all days of each 21 day cycles (segment 1).
Ipilimumab will be dosed on the 1st day of each 21 day cycle for the first 4 cycles.
Indoximod dosing will continue after all 4 doses of ipilimumab are administered (segment 2, 28-day cycles).
Indoximod will be administered at 1200mg BID by mouth.
Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
|
Phase 2: Indoximod + Nivolumab
n=4 participants at risk
Indoximod will be administered at 1200mg BID by mouth.
Nivolumab administered intravenously at 240 mg every 2 weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Nivolumab: Nivolumab administered intravenously at 240 mg every 2 weeks.
|
Phase 2: Indoximod + Pembrolizumab
n=114 participants at risk
Indoximod will be administered at 1200mg BID by mouth.
Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
Indoximod: Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
Dose escalation:
* If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
* If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
* If \> 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
* If \>1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If \>1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1
Pembrolizumab: Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
12.3%
14/114 • Number of events 14 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Cardiac disorders
Vertigo
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
14.9%
17/114 • Number of events 17 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Dry eye
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Corneal bleeding
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Optic atrophy
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Retinal aneurysm
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
2/6 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
44.7%
51/114 • Number of events 52 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
66.7%
4/6 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
38/114 • Number of events 38 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
28.9%
33/114 • Number of events 33 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
75.0%
3/4 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
23.7%
27/114 • Number of events 27 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
3/6 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
23.7%
27/114 • Number of events 27 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
10.5%
12/114 • Number of events 12 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
8.8%
10/114 • Number of events 10 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
8.8%
10/114 • Number of events 10 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.9%
9/114 • Number of events 9 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
66.7%
4/6 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
71.1%
81/114 • Number of events 81 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
14.9%
17/114 • Number of events 17 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
13.2%
15/114 • Number of events 15 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
13.2%
15/114 • Number of events 15 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
8.8%
10/114 • Number of events 10 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Thirst
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Device related thrombosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Early satiety
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Hypothermia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Medical device site pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Oedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
General disorders
Pneumatosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
66.7%
2/3 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
12.3%
14/114 • Number of events 14 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
6.1%
7/114 • Number of events 7 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Folliculitis
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Immune system disorders
Diverticulitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Lip infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Skin candida
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.9%
9/114 • Number of events 9 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
2/6 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
11.4%
13/114 • Number of events 13 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
8.8%
10/114 • Number of events 10 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
8.8%
10/114 • Number of events 10 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
8.8%
10/114 • Number of events 10 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
6.1%
7/114 • Number of events 7 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Bacterial test
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood creatine increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Troponin increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
75.0%
3/4 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.4%
29/114 • Number of events 29 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
6.1%
7/114 • Number of events 7 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
6.1%
7/114 • Number of events 7 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
28.1%
32/114 • Number of events 32 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
11.4%
13/114 • Number of events 13 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
10.5%
12/114 • Number of events 12 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
2/6 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.9%
9/114 • Number of events 9 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
24.6%
28/114 • Number of events 28 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemorrhage intracranial
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
34.2%
39/114 • Number of events 39 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
18.4%
21/114 • Number of events 21 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
19.3%
22/114 • Number of events 22 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
2/6 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
38/114 • Number of events 38 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Investigations
Dysphonia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
66.7%
4/6 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
31.6%
36/114 • Number of events 36 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
12.3%
14/114 • Number of events 14 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
2/6 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
23.7%
27/114 • Number of events 27 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
50.0%
2/4 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lymph node neoplasm
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm benign
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
6.1%
7/114 • Number of events 7 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
6.1%
7/114 • Number of events 7 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Aura
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Libido increased
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
7.0%
8/114 • Number of events 8 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
10.5%
12/114 • Number of events 12 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
9.6%
11/114 • Number of events 11 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
9.6%
11/114 • Number of events 11 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
33.3%
2/6 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hyperinflation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
100.0%
6/6 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
75.0%
3/4 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
36.8%
42/114 • Number of events 42 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
8.8%
10/114 • Number of events 10 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
5.3%
6/114 • Number of events 6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
3.5%
4/114 • Number of events 4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
1.8%
2/114 • Number of events 2 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
4.4%
5/114 • Number of events 5 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
2.6%
3/114 • Number of events 3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
25.0%
1/4 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/114 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/3 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/6 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.00%
0/4 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
0.88%
1/114 • Number of events 1 • Adverse events were captured from the first dose of study drug through study completion up to 24 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60